Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amgen, GC Pharma, Replimune, Roche, Servier, Tarsus.
Nearly a week after U.S. President Joe Biden called on Congress to get prescription drug pricing reform done, a House subcommittee took up dueling bills aimed at bringing down drug prices.
Stock-price weakness that has beset Chemocentryx Inc. since early March – likely based on jitters ahead of the FDA advisory panel for avacopan slated for May 6 – became an outright tumble when Wall Street got a gander at briefing documents related to the meeting. Shares of the San Carlos, Calif-based firm (NASDAQ:CCXI) closed at $22.19, down $26.63, or 45%, as company backers sifted paperwork on the complement C5a receptor inhibitor for anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis. The compound has been assigned a PDUFA date of July 7.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Astellas, Carmot, Clarity, Eli Lilly, Hutchmed, Immunomet, Newron, Pfizer, Quercis, R-Pharm Germany, Siga Technologies, Viiv Healthcare.
While last week’s marathon Oncologic Drugs Advisory Committee meeting to consider accelerated approvals for cancer drugs that didn’t demonstrate effectiveness in confirmatory trials was a good step forward, oncologists need the FDA to do more to ensure drug labeling truly reflects the benefit of the product.
To honor its part for phase one of the U.S.-China trade deal, China has revised its patent law to establish a drug patent linkage system and provide compensation for lost patent terms, similar to procedures under the U.S. Hatch-Waxman Act. Effective June 1, the new patent law is expected to drive biotech innovation and welcome more foreign drugs to the China market.
In a first for the biotech industry, the European Commission (EC) has imposed a €7.5 million (US$9.05 million) fine on Sigma-Aldrich, under the EU’s 2004 Merger Regulation, for providing incorrect or misleading information during a merger investigation.
Astrazeneca plc followed up its win a year ago in heart failure (HF) with yet another approval for its oral SGLT2 inhibitor, Farxiga (dapagliflozin), now cleared by the FDA to reduce the odds of kidney function decline, failure, cardiovascular death and hospitalization for HF in adults with chronic kidney disease (CKD) at risk of disease progression.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Advicenne, Amicus, Avrobio, Astrazeneca, Camurus, Chiesi, Clearside, Galmed, Intra-Cellular, Jacobio, Moderna.
Emergent Biosolutions Inc. CEO Robert Kramer assured investors that he takes “full responsibility” for woes that beset the firm after the FDA’s Form 483 found serious manufacturing problems at the Baltimore, Md.-based Bayview plant. “You have my commitment that we're going to do everything we can to resolve these issues quickly, and as safely as possible,” he said during an April 29 conference call on first-quarter financial results.
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