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Pharmaceuticals, health and wellness

Emergent BioSolutions’ plant behind the lost J&J vaccine batch hit with several FDA red flags last year: report

With Johnson & Johnson’s COVID-19 vaccine rollout off to a slower than expected start, the recent news that millions of doses were ruined in a production error came as a rude awakening. But the Emergent BioSolutions plant at the heart of the issue has faced scrutiny for its shortcomings from federal regulators before. An FDA investigator last […]

Sanofi’s Sarclisa forays into Darzalex’s new territory with FDA nod in earlier myeloma

Sanofi’s Sarclisa is keeping the heat on Johnson & Johnson’s Darzalex, following its in-class rival into new multiple myeloma territory. Sarclisa, used in tandem with Amgen’s proteasome inhibitor Kyprolis and steroid dexamethasone (Kd), has won FDA clearance to treat relapsed or refractory multiple myeloma after at least one prior treatment, Sanofi said Wednesday. The new […]

Sinovac aims to pump out 2B COVID-19 vaccine doses a year, courtesy of third production line

As COVID-19 vaccines rack up authorizations and roll out across the globe, the manufacturing push has taken center stage. Now, one of the key players supplying shots to China and other countries is touting a major production boost.  China’s Sinovac Biotech has built capacity to crank out 2 billion doses of its COVID-19 vaccine CoronaVac per year, thanks to […]

Gilead has sole rights to COVID-19 blockbuster Veklury, GAO concludes

Throughout the frantic response to the pandemic last year, drugmakers worldwide tested hundreds of potential treatments. Gilead’s antiviral remdesivir quickly rose to the top of treatment guidelines, and with the pandemic spiraling out of control, advocacy groups called on the U.S. government to step in and enforce patents against the company.  The federal government, advocates pointed out, has supported research on the medicine over […]

Nitto Denko lays out $226M to boost oligonucleotide production in a bustling RNA market

With oligonucleotides on the rise to treat rare diseases and cancers, Japanese manufacturer Nitto Denko is laying big plans.  Nitto will plug a whopping 25 billion yen ($225.93 million) into its Massachusetts-based subsidiary Nitto Denko Avecia, plus other companies in its fold, to beef up oligonucleotide production amid fast-growing demand. The cash will cover new buildings, a new commercial […]

On the heels of CFO scandal, former Eli Lilly exec alleges sex discrimination, harassment in bombshell lawsuit

Eli Lilly faced a high-level personnel scandal last month when CFO Josh Smiley left under a cloud of “inappropriate” communications with employees. But a sex discrimination lawsuit from a former internal lobbyist uncovers an entirely new controversy—and offers an alleged look inside the culture of a key team. Sonya Elling, a longtime biopharma lobbyist who […]

Bristol Myers, bluebird bio have their BCMA CAR-T nod, but latecomer J&J could have an advantage: analysts

Bluebird bio and partner Bristol Myers Squibb have outrun Johnson & Johnson and Legend Biotech in snagging the first FDA nod for a BCMA-targeted CAR-T therapy. But the label of the new drug, dubbed Abecma, could hand its upcoming competitor an advantage, analysts say. The FDA greenlighted Abecma, also known as ide-cel, for multiple myeloma […]

Bristol Myers Squibb, bluebird bio’s multiple myeloma CAR-T ide-cel scores FDA nod

After multiple regulatory setbacks on Bristol Myers Squibb’s lymphoma CAR-T drug Breyanzi caused investors headaches, the company on Friday scored its second cell therapy approval. The FDA endorsed Abecma, formerly known as idecabtagene vicleucel, to treat adult multiple myeloma patients who have received four or more prior lines of therapy. With the approval, Abecma becomes the first CAR-T med licensed in multiple myeloma and the first B-cell maturation antigen-targeted (BCMA) […]

CDMO Raybow adding 74 jobs in the hills of North Carolina at its U.S. headquarters

A budding CDMO in the Blue Ridge Mountains of North Carolina is ready to grow significantly. Over the next five years, Raybow Pharmaceuticals will invest $15.8 million and add 74 jobs at its North American headquarters in Brevard. Its workforce there will quadruple and production capacity will increase tenfold as the parent company looks to grow […]

BioNTech nabs EU approval for Novartis plant tapped in COVID-19 vaccine production push

On a quest to turn out 2 billion doses of their COVID-19 vaccine Comirnaty this year, Pfizer and BioNTech just scored a major boost thanks to the European approval of a linchpin manufacturing plant in Germany.  BioNTech won a thumbs up from the European Medicines Agency (EMA) to start making and supplying partners with vaccine drug product from the Marburg, Germany facility it picked up from Novartis […]

Novartis sets the record straight on chairman’s $678M kickback settlement comments

Novartis has set the record straight after chairman Joerg Reinhardt mischaracterized behavior the company admitted to in its U.S. kickback settlement last July.  In a March 6 interview with Swiss newspaper SonntagsBlick, Reinhardt took issue with the use of the term “bribery” to describe the company’s conduct between 2002 and 2011, when U.S. federal prosecutors claim Novartis used […]

FDA’s second-in-command Abernethy leaving agency as Biden’s commissioner yet to be named

After just two years at the FDA, principal deputy chief Amy Abernethy is leaving the agency. As second-in-command and acting chief information officer, Abernethy oversaw tech and data modernization at the FDA and launched its COVID-19 accelerator project to boost real-world data gathering. Her unexpected departure comes as the search for a permanent FDA commissioner continues two […]