FDA Pharmaceutical and Medical Device Headline News

Devicemaker Steris made several significant changes to an FDA-cleared product — changes that warranted a new premarket submission, according to a recent warning letter.  Read More

As legislators try to reverse a Supreme Court preemption ruling for medical devices, a House committee is questioning the FDA, alleging the agency changed its position on preemption.  Read More

Devicemakers that were invited to but did not participate in the joint U.S.-Canadian pilot multipurpose audit program (PMAP) are a priority for FDA inspection, according to an agency director.  Read More

U.S. device firms choosing Asian distributors must be more “street smart” than when they work in Europe because of cultural and regulatory differences, an expert says.  Read More

The House passed a bill last week that would delay implementation of Medicare’s durable medical equipment, prosthetics, orthotics and supplies (DMEPOS) competitive bidding program.  Read More

The U.S. and Vietnam have signed a three-year, renewable memorandum of understanding (MOU) to enhance the safety of medical devices and drugs traded between the two nations.  Read More

Devicemakers Steris and Cardinal Health are facing a class action lawsuit after surgical instruments at two hospitals were sterilized in hydraulic waste fluid from elevators rather than Steris cleaning solutions.  Read More

A sponsor-investigator in a device clinical trial failed to get FDA approval before fitting patients with experimental prostheses, according to the agency.  Read More

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Due to summer holidays, Devices & Diagnostics Letter will not be published July 7. The next issue will be published July 14.  Read More

As part of Medtronic’s efforts to rein in costs, a large portion of its anticipated savings will come from reducing the cost of manufacturing, a company executive said.  Read More

Boehringer Ingelheim recalled 2.2 million Zantac tablets last month because the drug exceeded limits for S-oxide, an impurity.  Read More

Pfizer, the world's largest drugmaker, has agreed to pay a $975,000 civil penalty to resolve alleged violations of the Clean Air Act at its former manufacturing plant in Groton, Conn., federal officials announced.  Read More

China is getting a replica of Dr. Norman Bethune's childhood home as part of a venture in which Microbix Biosystems Inc. is joining a Chinese provincial government in an influenza vaccine production plant.  Read More

NanoGuardian, a division of NanoInk that focuses exclusively on delivering brand protection solutions to fight illegal diversion and counterfeiting, announced that the Food and Drug Administration (FDA) has issued approval to a NanoGuardian client to use NanoGuardian's … NanoEncryption technology as an on-dosage, brand protection technology.  Read More

Johnson Medtech, the medical products group of Johnson Electric, one of the world’s largest providers of motion actuators, announced the opening of four new cleanrooms in Shajing, China.  Read More

Bafna Pharmaceuticals (Bafna), a multi-product pharmaceutical formulations company in diverse therapeutic segments, has received Medicines and Health Care Products Regulatory Agency (MHRA) approval for its facility meant for exports to the UK markets and European Union.  Read More

Alder is looking for experts in antibody manufacturing and clinical development, including a director of clinical operations, a medical director and clinical-study managers.  Read More

Due to summer holidays, Washington Drug Letter will not be published July 7. The next issue will be published July 14.  Read More

Drugmakers waiting for the U.S. Supreme Court’s decision on preemption in Wyeth v. Levine later this year could be affected by the Medical Device Safety Act of 2008, introduced last week by House lawmakers to preserve state product liability lawsuits.  Read More

Pfizer will pay a $975,000 civil penalty for alleged Clean Air Act violations at a former manufacturing plant, a fee the Justice Department hopes will serve as a warning to pharma about hazardous emissions.  Read More

The U.S. and Vietnam signed a three-year, renewable memorandum of understanding (MOU) last week to enhance the safety of drugs and medical devices traded between the two nations.  Read More

The first version of the Clinical Data Acquisition Standards Harmonization (CDASH) initiative will be available for clinical research use by early September, enabling sites to follow incompatible standards used by different sponsors, project director Rhonda Facile said.  Read More

Merck will respond in July to an FDA rejection of its sBLA for cervical cancer vaccine Gardasil in women age 27–45, according to the company.  Read More

Taro Pharmaceutical Industries has received final FDA approval to manufacture and market a generic version of McNeil Consumer Healthcare’s prescription Zyrtec syrup 1 mg/mL to treat symptoms of seasonal allergic rhinitis.  Read More

Jerini plans to submit a complete response to a not-approvable letter it received last week for Icatibant as a treatment for hereditary angioedema (HAE).  Read More

Ranbaxy Laboratories has received tentative approval from the FDA to manufacture and market valganciclovir HCl 450-mg tablets, a generic version of Roche’s antiviral Valcyte.  Read More

Drugmakers waiting for the U.S. Supreme Court’s decision on preemption in Wyeth v. Levine later this year could be affected by the Medical Device Safety Act of 2008, introduced in the House to preserve state product liability lawsuits.  Read More

The FDA has approved GlaxoSmithKline’s Avodart in combination with tamsulosin to treat enlarged prostate.  Read More

Glenmark Generics, a subsidiary of Indian drugmaker Glenmark, has received FDA approval for its ANDA to market a generic version of Abbott Laboratories’ blood pressure drug Mavik in 1-, 2- and 4-mg strengths.  Read More

Amgen's experimental osteoporosis drug denosumab could have difficulty gaining Food and Drug Administration approval in its initial try, due to a higher incidence of infections compared with placebo seen in some patients, according to an osteoporosis doctor who conducted clinical trials for Amgen.  Read More

Women with metastatic breast cancer who developed an immune response to an investigational vaccine lived twice as long as those who didn't have an immune response, new research shows.  Read More

After a two-year run, pharmaceutical giant Wyeth is parting ways with Publicis Groupe's Kaplan Thaler Group, placing creative duties on the $55 million marketing account for its Centrum brand into review, the client said.  Read More

The Economic Development Corp. of Kansas City announced an expansion of its incubator for early-stage life sciences companies, the Kansas City Biotechnology Center.  Read More

U.S. rabies vaccine supplies are "limited," the [Center for Disease Control and Prevention] says.  Read More

Millipore Corporation, a Life Science leader providing technologies, tools and services for bioscience research and biopharmaceutical manufacturing, unveiled a major expansion of its St. Charles, Missouri facility headquarters for its Drug Discovery Business Unit.  Read More

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The FDA has approved GlaxoSmithKline’s Avodart in combination with tamsulosin to treat enlarged prostate.  Read More

The FDA’s review of GlaxoSmithKline’s (GSK) investigational chronic idiopathic thrombocytopenic purpura (ITP) treatment Promacta has been extended until Sept. 19, the company said last week.  Read More

The FDA has a new assistant commissioner for policy, David Horowitz, who previously was the executive responsible for managing policy issues in the Office of Regulatory Affairs (ORA).  Read More

GlaxoSmithKline (GSK) has received FDA approval for Kinrix, the first combination vaccine to offer protection against diphtheria, tetanus, pertussis and polio diseases in one shot.  Read More

The review period for Eli Lilly and Daiichi Sankyo’s antiplatelet drug prasugrel has been extended to Sept. 26 as the FDA reviews supplemental analyses that were submitted after the original NDA was filed.  Read More

Genta has received notification from the FDA that it may resume clinical trials with its oncology drug tesetaxel.  Read More

Glenmark Generics, a subsidiary of Indian drugmaker Glenmark, has received FDA approval for its ANDA to market a generic version of Abbott Laboratories’ blood pressure drug Mavik in 1-, 2- and 4-mg strengths.  Read More

The FDA approved an expanded indication last week for Millennium Pharmaceuticals’ cancer drug Velcade, which is now indicated as a first-line treatment for multiple myeloma.  Read More

Boston Scientific is selling its investments in several companies and venture funds as part of its effort to pay down debt.  Read More

St. Jude Medical has performed its first patient implants in a clinical study that is investigating whether deep brain stimulation therapy will help people who suffer from major depressive disorder and have not responded to available treatments.  Read More

Aerocrine’s hand-held airway inflammation monitor, Niox Mino, has been registered for marketing and sale in China for the treatment of asthma.  Read More

A harmless laser might be able to spot the tangled proteins in brain tissue associated with Alzheimer’s disease in a living person – the structures can today only be found by dissecting the brain after death.  Read More

Researchers have devised a new breast-imaging technology that appears to be as accurate as MRI scans but several times cheaper.  Read More

Dako … has entered into a collaboration with Bristol-Myers Squibb Company to develop pharmacodiagnostic tests intended to identify patients more likely to benefit from treatment with certain investigational cancer drug candidates under development by Bristol-Myers Squibb.  Read More

Echolocation is a method of perceiving the world by emitting noises, then listening to the reflections of these noises off objects in the environment.  Read More

A new implantable medical device, developed in collaboration with Mayo Clinic researchers, shows promise as a reversible and less extreme alternative to existing bariatric surgeries, according to findings published in the current issue of the journal Surgery.  Read More

A self-cleaning surface that shakes off the body’s defence response could help keep biosensors working for longer inside the human body.  Read More

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The Senate approved a supplemental appropriations bill last week, giving the FDA an additional $150 million for this fiscal year if the president signs it.   Read More

Barr Laboratories and Mylan Pharmaceuticals have prevailed in a patent infringement case involving generic versions of Boehringer Ingelheim’s Parkinson’s disease drug Mirapex.  Read More

Schering-Plough and Merck have withdrawn their NDA for a combination tablet to treat allergic rhinitis symptoms.  Read More

The European Medicines Agency (EMEA) is recommending an update to the product information for etoricoxib-containing medicines on the risk of cardiovascular side effects.  Read More

The FDA has granted orphan drug status to DuoCort, a hydrocortisone dual-release oral tablet, which is being developed by the Swedish company DuoCort Pharma to treat adrenal insufficiency.  Read More

Indian drugmaker Cipla has received FDA approval for its HIV treatment zidovudine oral solution 50 mg/5 mL, a generic version of GlaxoSmithKline’s Retrovir.  Read More

As legislators try to reverse a Supreme Court preemption ruling for medical devices, a House committee is questioning the FDA, alleging the agency changed its position on preemption.  Read More

People in low-resource countries who have multidrug-resistant tubercolosis (MDR-TB) will get a faster diagnosis — in two days rather than the standard two to three months — and appropriate treatment due to two new initiatives unveiled by the World Health Organization (WHO), the Stop TB Partnership, UNITAID and the Foundation for Innovative New Diagnostics.  Read More

Midterm performance data for CryoLife’s CryoValve SG decellularized pulmonary human heart valve are promising, the company says.  Read More

Doctors often seem to prescribe CT and MRI scans when they are of little or no medical use, perhaps explaining why Canadians still face hefty delays to get the tests, a new Ontario study suggests.  Read More

In the past decade, hip- and knee-replacement surgery has exploded — nearly doubling to about 750,000 operations a year and fueling a multibillion-dollar implant industry with profit margins approaching 20 percent.  Read More

Researchers at the Fraunhofer Institute in Germany are using Affymetrix’s Whole Transcript gene expression technology to develop a diagnostic test to detect drug-induced liver toxicity, the company said.  Read More

A new assistive technology developed by engineers at the Georgia Institute of Technology could help individuals with severe disabilities lead more independent lives.  Read More

Patients suffering from severe arthritis now have an option for total ankle replacement that offers increased mobility and pain relief without permanent metal implants.  Read More

Patches that deliver nitroglycerin through the skin do nothing to help speed healing from a common type of injury to the Achilles tendon, UK researchers have found.  Read More

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Roche and Genentech’s cancer agent Avastin is effective against colorectal cancer tumors that have both wild-type and mutated K-Ras genes, unlike other biologic therapies, according to data presented at a European oncology conference.  Read More

Watson Pharmaceuticals has launched the authorized generic version of Solvay Pharmaceuticals’ once-daily nausea drug Marinol in 2.5-, 5- and 10-mg strengths.  Read More

ATL/TV1102 significantly reduced the number of new active lesions in patients with relapsing-remitting multiple sclerosis in a Phase IIa study, according to Teva Pharmaceutical and Australian drugmaker Antisense Therapeutics.  Read More

Health Canada has authorized Basilea Pharmaceutica to market its first-in-class broad-spectrum antibiotic Zeftera to treat complicated skin and soft tissue infections, including diabetic foot infections, the company said.  Read More

Results from two clinical trials show that Zogenix's needle-free DosePro formulation of the migraine drug sumatriptan reaches peak levels in patients’ blood in minutes.  Read More

GlaxoSmithKline (GSK) has sold the intellectual property (IP) rights to four branded drugs for roughly $339 million to Aspen Global.  Read More

The Senate approved a supplemental appropriations bill last week, giving the FDA an additional $150 million for this fiscal year if the president signs it.  Read More

Taro Pharmaceutical Industries has received final FDA approval to manufacture and market a generic version of McNeil Consumer Healthcare’s prescription Zyrtec syrup 1 mg/mL to treat symptoms of seasonal allergic rhinitis.  Read More

The FDA has approved Warner Chilcott’s 150-mg strength Doryx delayed-release tablets to treat acne.  Read More

GSK said it doesn’t expect the U.S. Food and Drug Administration to require additional studies for its vaccine to prevent cervical cancer before it can gain approval.  Read More

Durect Corp., a specialty pharmaceutical company, announced that the U.S. Food and Drug Administration, or FDA, granted orphan drug designation for bupivacaine, the active pharmaceutical ingredient in the investigational transdermal drug patch Eladur.  Read More

Pharmaceutical manufacturers want a crackdown on the practice of buying cheap medicines to re-export at a higher price, a trade that creates shortages in countries such as Greece — and, arguably, allows in dangerous counterfeits.  Read More

International research involving the University Hospital of the University of Navarra, together with other hospitals in Spain, has shown that Sorafenib, an orally administered pharmaceutical medicine, results in patients with primary hepatocarcinomas (liver tumours) to live 40% more on average compared to those not taking the drug.  Read More

J&JPRD, a drug discovery and drug development company and part of Johnson & Johnson, announced … that the company has received approval from the US Food and Drug Administration (FDA) for its Supplemental New Drug Application (sNDA) for CONCERTA (methylphenidate HCI) extended-release tablets for ADHD in adults ages 18 to 65.  Read More

Roche, the makers of the leading bird flu vaccine, Tamiflu, have laid out plans and are urging companies to buy stockpiles of the vaccine in the case of an influenza pandemic.  Read More

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Roche and Genentech’s cancer agent Avastin is effective against colorectal cancer tumors that have both wild-type and mutated K-Ras genes, unlike other biologic therapies, according to data presented at a European oncology conference.  Read More

The FDA has a new assistant commissioner for policy, David Horowitz, who previously was the executive responsible for managing policy issues in the Office of Regulatory Affairs (ORA).  Read More

The FDA has approved Sirion Therapeutics’ Durezol, a topical steroid used to treat postoperative ocular inflammation and pain.  Read More

If talent crunch was not enough, the pharmaceutical industry in India is facing another pressing issue — patient crunch.  Read More

The chief clinical and regulatory affairs official at Inspire Pharmaceuticals is leaving the company.  Read More

Eisai Corporation of North America, a wholly-owned subsidiary of Tokyo-based Eisai Co., Ltd., announced that the Food and Drug Administration (FDA) has approved ACIPHEX (rabeprazole sodium) 20 mg for the short-term (up to eight weeks) treatment of gastroesophageal reflux disease (GERD) in adolescents ages 12 and above.  Read More

Pharmaceutical company SuperGen Inc. said Tuesday its drug candidate Dacogen was not effective in treating a type of bone marrow disorder in a late-stage study.  Read More

AMDL … announced a letter of intent has been signed between AMDL's wholly-owned subsidiary Jade Pharmaceutical Inc. and China-based Sichuan ZhiTong Pharmaceutical, Ltd. (SZP).  Read More

Depomed will borrow $15 million from Oxford Finance Corp. and GE Healthcare Financial Services to help pay for a hot flash treatment program.  Read More

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Greer has finished enrolling patients for its Phase III clinical trial studying sublingual-oral immunotherapy as a treatment for adults with allergic rhinoconjunctivitis caused by short ragweed pollen.  Read More

Using Merck’s investigational drug telcagepant, a Phase III trial showed improvement in patients’ pain and symptom relief from migraines.  Read More

After disappointing Phase III trial results, Myriad is discontinuing its development of Flurizan for Alzheimer’s disease.  Read More

DOR BioPharma is collaborating with Numoda, a clinical trials information services company, in its upcoming confirmatory Phase III clinical trial of orBec in the treatment of gastrointestinal graft-versus-host disease (GI GVHD).  Read More

Vivus’ Phase II study for Qnexa, used for treating cardiovascular complications that arise from Type 2 diabetes, produced positive results.  Read More

Mpex Pharmaceuticals has begun a Phase II clinical study with MP-376 for the treatment of pulmonary infections in patients with cystic fibrosis (CF).  Read More

MethylGene has initiated a Phase II clinical trial evaluating MGCD0103 in combination with injections of Vidaza for patients with high-risk myelodysplastic syndromes or acute myeloid leukemia.  Read More

GPC Biotech is beginning a clinical trial testing satraplatin combined with the steroid prednisone in patients with metastatic hormone-refractory prostate cancer who have been treated with docetaxel, a chemotherapy drug.  Read More

Patients who are addicted to methamphetamine are enrolling in Catalyst Pharmaceuticals’ Phase II clinical trial using CPP-109.  Read More

A Phase II clinical trial is under way for BioMarck Pharmaceuticals’ study of BIO-11006 inhalation solution for chronic obstructive pulmonary disease (COPD).  Read More

Favorable interim results were seen in Celsion’s second Phase I liver cancer study of ThermoDox combined with radio-frequency ablation (RFA) in treating patients with primary and metastatic liver cancer.  Read More

Data from Cytokinetics’ Phase Ib trial evaluating ispinesib in combination with capecitabine, an oral chemotherapy agent commonly used in the treatment of breast cancer, support the ongoing development of ispinesib, the company said.  Read More

The University of Kansas Cancer Center is beginning a Phase I trial to study Nanotax, a reformulated version of Paclitaxel, for ovarian cancer.  Read More

The FDA gave orphan drug designation to Hana Biosciences for Marqibo sulfate injection for the treatment of adult patients with metastatic uveal melanoma.  Read More

United Therapeutics and its wholly owned subsidiary, Lung Rx, have filed an NDA for an inhaled formulation of treprostinil in the treatment of pulmonary arterial hypertension (PAH).  Read More

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Devicemakers that were invited to but did not participate in the joint U.S.-Canadian pilot multipurpose audit program (PMAP) are a priority for FDA inspection, according to an agency director.  Read More

The FDA has granted 510(k) clearance to SenoRx for a second design of its Contura Multi-Lumen Radiation Balloon (MLB) short-term breast radiation device.  Read More

Animas received FDA clearance for its OneTouch Ping glucose management system.  Read More

A laser treatment that wipes out drug-resistant bacterial infections may one day help doctors tackle the growing problem of superbugs, British researchers said.  Read More

Scientists are improving breast cancer detection in women with the help of 3-D technology.  Read More

Bausch & Lomb announced that it has received approval from the Food and Drug Administration (FDA) to market the Crystalens HD in the United States.  Read More

Interventional Spine, Inc. announced that the U.S. Food and Drug Administration has approved the Company's investigational device exemption (IDE) application for its PercuDyn System for the treatment of degenerative disc disease (DDD).  Read More

A&D Medical and FitLinxx, Inc. announced a partnership to deliver a comprehensive set of wireless medical devices to address the demands of the home and professional healthcare markets.  Read More

An interventional cardiology team … successfully placed a vProtect Luminal Shield in the left anterior descending (LAD) coronary artery of a 64-year-old man at Erasmus Medical Center in Rotterdam.  Read More

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Clinical trial designs for diabetes drugs are not good enough at detecting cardiovascular risk with GlaxoSmithKline’s (GSK) Avandia being Exhibit A, according to experts at a Tuesday meeting of CDER’s Endocrinologic and Metabolic Drugs Advisory Committee.  Read More

In response to the FDA’s final approval of Teva’s generic Risperdal, Janssen has launched an authorized generic version of the anti-psychotic through Patriot Pharmaceuticals.  Read More

Peregrine Pharmaceuticals has won a five-year U.S. government contract to develop its monoclonal antibody bavituximab and a fully human equivalent as broad-spectrum anti-viral agents.   Read More

The FDA is looking for companies to participate in its quality-by-design (QbD) pilot program for biotechnology submissions, which is intended to help the agency develop guidance on the topic.  Read More

In the wake of the safety concerns over tainted heparin and the push to ensure the safety of pharmaceuticals, the Interagency Working Group on Import Safety has issued a progress report updating initiatives to enhance the safety of imported goods.  Read More

Clinical trial designs for diabetes drugs are not good enough at detecting cardiovascular risk with GlaxoSmithKline’s (GSK) Avandia being Exhibit A, according to experts at a Tuesday meeting of CDER’s Endocrinologic and Metabolic Drugs Advisory Committee.  Read More

New clinical trial technologies pose increasingly difficult problems that research sites must be prepared to resolve, experts say.  Read More

Ranbaxy Laboratories has received tentative approval from the FDA to manufacture and market valganciclovir HCl 450-mg tablets, a generic version of Roche’s anti-viral Valcyte.  Read More

Drug maker Glenmark Pharmaceuticals said that it has signed agreements with Iceland-based Actavis to acquire seven pharmaceutical brands in Poland for an undisclosed amount.  Read More

Cubist Pharmaceuticals Inc. has signed an exclusive agreement to promote AstraZeneca Plc.’s antibiotic MERREM … which is used for treating appendicitis, peritonitis, complicated skin and skin structure infections, and pediatric bacterial meningitis.  Read More

EPIX Pharmaceuticals … announced that the New Drug Application for its novel blood pool magnetic resonance angiography agent, Vasovist (gadofosveset trisodium) was resubmitted to the U.S. Food and Drug Administration on June 30, 2008.  Read More

FDC announced that the company has obtained an approval from US FDA for its Abbreviated New Drug Application Ciprofloxacin Ophthalmic Solution that is used for occular surface infections.  Read More

MiddleBrook Pharmaceuticals … announced that its Board of Directors has completed its previously announced review of strategic alternatives and has entered into an agreement with Equity Group Investments, L.L.C. (EGI) for a $100 million equity investment in the company.  Read More

After six days of deliberation, a jury found [Melbourne] Mills — who argued that he was too drunk to take part in a criminal conspiracy — not guilty of taking millions from his former clients in a $200 million fen-phen settlement.  Read More

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U.S. device firms choosing Asian distributors must be more “street smart” than when they work in Europe because of cultural and regulatory differences, an expert says.  Read More

Premier Research Group, an international pharmaceutical services company, received International Organization for Standardization (ISO) 13485:2003 certification for its global medical device operations.  Read More

The FDA has granted 510(k) clearance to Hansen Medical for its CoHesion 3-D visualization module for use in complex electrophysiology mapping procedures.  Read More

The UCSD $50K Competition announced that NeuroVigil Inc., a Salk Institute spin off, has won first prize of $30,000 for innovation in brain analysis.  Read More

Abbott has invested a second $20 million in pathogen detection developer Ibis Biosciences…. Ibis plans to use the cash to develop its T5000 Biosensor System, a system for rapidly identifying and characterizing infectious agents, including pandemic diseases, emerging or previously unknown pathogens, and hospital-acquired infections.  Read More

Celera Corp. has separated from its parent company and ended its run as a high-flying local biotechnology firm.  Read More

Until recently, microbleeds were all but unknown. Now, with improved scans, they are turning up constantly; one recent study found them in the brains of 1 out of 5 people age 60 and older.  Read More

Freedom Sciences LLC of Philadelphia has received approval from the Food and Drug Administration for a module that advances the use of motorized wheelchairs.  Read More

St. Jude Medical, Inc. and EP MedSystems, Inc. announced that in connection with the previously announced acquisition of EP MedSystems by St. Jude Medical, the final exchange ratio is 0.0738 (rounded) for the stock portion of the consideration.  Read More

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Makers of new diabetes drugs or biologics with no cardiovascular safety signal during clinical trials should submit long-term cardiovascular trial results or provide other evidence to rule out an unacceptable level of cardiovascular risk, an FDA advisory committee says.  Read More

AstraZeneca has won a patent dispute with Teva and Sandoz over its anti-psychotic Seroquel.  Read More

GlaxoSmithKline (GSK) and Novartis plan to appeal an Alabama jury verdict that would cost them $80.9 million and $33.2 million, respectively.  Read More

Bayer is acquiring Maxygen’s hemophilia program, including a next-generation recombinant Factor VIIa protein, for $90 million upfront and a final potential milestone payment of $30 million.  Read More

AstraZeneca is suing Dr. Reddy’s Laboratories for patent infringement after the Indian drugmaker submitted an application to sell a generic version of the asthma drug Accolate.  Read More

Jack Distribution is voluntarily recalling certain lots of its Rize 2 The Occasion capsules and Rose 4 Her capsules because they contain an undeclared ingredient similar to the active ingredient of an erectile dysfunction (ED) drug.  Read More

In observance of the Independence Day holiday, Drug Industry Daily will not be published Friday, July 4. The next issue will be published Monday, July 7.  Read More

Devicemakers that were invited to but did not participate in the joint U.S.-Canadian pilot multipurpose audit program (PMAP) are a priority for FDA inspection, according to an agency director.  Read More

Devicemakers Steris and Cardinal Health are facing a class action lawsuit after surgical instruments at two hospitals were sterilized in hydraulic waste fluid from elevators rather than Steris cleaning solutions.  Read More

The FDA’s launch of Sentinel, an initiative designed to transform the agency’s postmarket surveillance, will likely not place additional regulatory burdens on devicemakers, according to an agency director.  Read More

Bayer HealthCare (BHC) announced that BHC's Consumer Care Division has achieved the necessary regulatory approvals to complete the acquisition of the Western over-the-counter (OTC) cough and cold portfolio of Topsun Science and Technology Qidong Gaitianli Pharmaceutical Co., Ltd by Bayer Healthcare Company Limited in China.  Read More

Brisbane-based Progen Pharmaceuticals Limited announced the "spin-out" of its manufacturing business as the wholly owned subsidiary company PharmaSynth Pty Ltd.  Read More

Cantel Medical, a provider of infection-prevention products, said its Minntech Corp. subsidiary will move all of its Dutch manufacturing operations to the United States.  Read More

A Virginia-based pharmaceutical company is opening a plant, creating 55 new jobs. Galexe Pharma Sciences, a subsidiary of Excela PharmSci Inc., is investing $8.6 million in the plant over the next three years.  Read More

CytoDyn has begun GMP manufacturing and humanization of Cytolin, a monoclonal antibody that uses the human immune system to control HIV infection.  Read More

Imtech will realise much of the technology in the CDPP project (Chemical Development Pilot Plant) in Geel for Janssen Pharmaceutica (part of the American pharmaceutical group Johnson & Johnson).  Read More

Makers of new diabetes drugs or biologics with no cardiovascular safety signal during clinical trials should submit long-term cardiovascular trial results or provide other evidence to rule out an unacceptable level of cardiovascular risk, an FDA advisory committee says.  Read More

The FDA has granted orphan drug status to DuoCort, a hydrocortisone dual-release oral tablet, which is being developed by the Swedish company DuoCort Pharma to treat adrenal insufficiency.  Read More

Indian drugmaker Cipla has received FDA approval for its HIV treatment zidovudine oral solution 50 mg/5 mL, a generic version of GlaxoSmithKline’s Retrovir.  Read More

Labopharm announced that it has submitted a complete response to the Food and Drug Administration (FDA) … as the next step in the regulatory path towards potential U.S. approval of the Company's once-daily formulation of tramadol.  Read More

Paladin Labs and Procter & Gamble (P&G) Pharmaceuticals Canada announced that the companies have entered into a Canadian Co-Promotion Agreement for Seasonale.  Read More

A former executive assistant at Pfizer will not serve prison time after agreeing to pay back nearly $130,0000 that she embezzled.  Read More

Akorn, Inc. a specialty pharmaceutical company and Bioniche Pharma have entered into a five-year commercial manufacturing and supply agreement for two undisclosed pharmaceutical products.  Read More

A British man caught dealing in counterfeit medicines worth at least 1.8 million pounds ($3.57 million) has received a 51 week suspended prison sentence, the country's drugs regulator said.  Read More

Patheon, a global provider of drug development and manufacturing services to the international pharmaceutical industry, has completed a shareholders agreement and a sales and marketing agreement with Italy's BSP Pharmaceuticals, a company focused on the development and manufacturing of cytotoxic pharmaceutical products.  Read More

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The House passed a bill that would delay implementation of Medicare’s durable medical equipment, prosthetics, orthotics and supplies (DMEPOS) competitive bidding program.  Read More

Quantum Dental Technologies has developed a technology prototype that detects and monitors the early onset of tooth decay without using dental X-rays.  Read More

The Chinese State Food and Drug Administration granted approval to Chindex International for the launch of new surgical products.  Read More

A new device meant to make surgical treatment of ear infections safer and faster has been developed by a University of Virginia team.  Read More

A Montreal-based drug company has gone to court in an unusual attempt to block Health Canada from further distributing an article on alleged problems with one of its products.  Read More

Dutch scientists launched field tests in India of universal spectacles they have designed to help the vision of children in developing countries.  Read More

Boston researchers have developed a test that can identify minute amounts of tumor cells floating in the blood of cancer patients, a discovery that could lead to better treatments with fewer side effects.  Read More

Compact, bedside brain-activity monitors detected most seizures in at-risk infants, researchers at Washington University School of Medicine in St. Louis showed.  Read More

Glaucoma doesn’t necessarily have to end in blindness, two new studies suggest.  Read More

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Pfizer will no longer fund physician continuing medical education (CME) programs provided by medical education and communication companies, the company said.  Read More

An FDA warning letter to a clinical investigator zeroed in on her use of English-language informed consent forms with Spanish-speaking patients, among other issues.  Read More

The FDA has lifted its clinical hold on an IND for Adolor and GlaxoSmithKline’s (GSK) Entereg to treat chronic opioid bowel dysfunction (OBD).  Read More

Shire has agreed to acquire Berlin-based Jerini, including the company’s treatment for a potentially life-threatening tissue swelling, for roughly $520 million.  Read More

APP Pharmaceuticals has received final approval from the FDA for its ANDA to market a generic version of Roche’s Kytril in 1-mg/mL, 1-mL single-dose and 1-mg/mL, 4-mL multiple-dose vials, according to APP.  Read More

Mylan Pharmaceuticals has received tentative approval from the FDA for a generic version of Pfizer’s Zyvox 600-mg tablets.  Read More