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To simplify the Institutional Review Board review process, the National Institutes of Health is requiring a single IRB to oversee multi-site research of non-exempt human subjects funded by the institute. Read More
Even with an abundance of FDA work left undone with biosimilars, industry development activities seem unaffected, with many “extremely active” in that space, an agency official says. Read More
The U.S. Supreme Court has asked the solicitor general to consider if a lower court erred in mandating that Novartis wait six months after approval of a biosimilar before going to market. Read More
The introduction of biosimilars to certain European countries has lowered drug prices by 50 percent to 60 percent in certain therapy areas, a report says. Read More
The UK’s drug pricing watchdog is recommending reimbursement of Bristol-Myers Squibb’s melanoma combination treatment of Opdivo and Yervoy, provided the company discounts the latter. Read More
The Justice Department was handed a surprise setback Friday when a jury acquitted Warner Chilcott’s former president of conspiring to pay kickbacks to physicians for prescribing seven of the company’s drugs. Read More