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Pharmaceuticals, health and wellness

Roche, Blueprint catch up with Lilly as Gavreto snags FDA thyroid cancer nod

When Roche and Blueprint Medicine’s Gavreto got the FDA go-ahead in September to challenge Eli Lilly’s first-to-market Retevmo, the newer entrant lacked an indication boasted by its rival. But now, a new FDA greenlight has leveled the playing field. The FDA has approved Gavreto in advanced or metastatic RET-mutant medullary or RET fusion-positive thyroid cancer, […]

Pfizer, BioNTech nabs COVID-19 vaccine authorization from U.K. for first-ever marketed mRNA shot

Pfizer and BioNTech have made history. The two companies’ BNT162b2 has become the first COVID-19 vaccine allowed in the Western world as drug regulators in the U.K. doled out an emergency use authorization on Wednesday, ahead of decisions by the U.S. and Europe, which are expected soon this month. For the broader vaccine world, the […]

Revance’s frown-line injection latest to face regulatory delay after FDA can’t hit inspection deadline

As COVID-19 continues to rage around the globe, the FDA’s inspection schedule has fallen into complete shambles—often to the detriment of drugmakers looking to bring new therapies to market. But the delays are hitting the aesthetics business, too, and now another drugmaker has had to hit the pause button.  Revance will have to wait for […]

Covaxx inks supply deals worth $2.8B in lead-up to coronavirus vaccine midstage trials

While some of the leading players in the race for a COVID-19 vaccine are racing toward the finish line, a range of smaller challengers is still hoping to carve out a market niche in the coming months. One of those, New York’s Covaxx, is rolling out its first swath of supply deals—and touting its shot’s logistics […]

Feds on COVID-19 mRNA vaccine distribution: Pfizer’s dry runs predict a ‘very doable process’

What will it take to distribute the first 6.4 million doses of Pfizer’s COVID-19 mRNA vaccine, if all goes according to plan and they ship in mid-December? Alex Azar, secretary of health and human services, acknowledged during a press conference Tuesday that the logistics—which include the need for ultra-cold storage—will be far from easy. But […]

CureVac ties up Wacker to churn out more than 100M doses of mRNA coronavirus vaccine

Riding a wave of interest in mRNA-based vaccines, Germany’s CureVac is looking to rapidly drive manufacturing of its own shot candidate. After announcing a plan to bring more partners on board, CureVac has knotted the first of those deals to the tune of 100 million doses. CureVac has tagged German chemical company Wacker to churn […]

Johnson & Johnson assures docs and patients its Janssen pharma unit ‘Never Stops’

Johnson & Johnson’s Janssen wants patients and doctors to know they can still count on the drugmaker—even during a pandemic. A new corporate campaign from the pharma arm of Johnson & Johnson reassures people it continues to develop and produce medicines, even as its scientists also work on a COVID-19 vaccine. The “Janssen Never Stops” digital […]

Baxter’s CDMO arm will add 100 new positions in $50M fill-finish expansion of Indiana plant

In recent months, the contract manufacturing market has seen a wave of investment in the U.S. amid the COVID-19 pandemic and a call for “onshore” drug production. Now, Baxter’s CDMO arm is stepping up to the plate with a finishing technology expansion at its Indiana site.  Baxter Biopharma Solutions, the CDMO arm of healthcare giant […]

Moderna to file COVID-19 shot for emergency nod in November, with Pfizer rollout pegged for early next month: Slaoui

As a tide of late-stage data rolls in on COVID-19 vaccines from Pfizer, Moderna and AstraZeneca, the U.S. is gearing up for reviews that could see a vaccine authorized and deployed before the year is out. On Saturday, the chief of the White House’s Operation Warp Speed effort laid out a definitive timeline, setting expectations for […]

ApiJect snares $590M government loan for ‘Gigafactory’ to produce billions of pre-filled vaccine injectors per year

As a number of COVID-19 vaccines race toward the regulatory finish line, the U.S. government is looking to shore up its fill-finish prospects through a massive investment in Stamford, Connecticut’s ApiJect Systems—maker of a plastic, pre-filled injector designed to ween the nation off its glass vial and syringe habit. ApiJect on Thursday was approved by the U.S. International Development Finance […]

Trump to unveil international pricing index, rebate crackdown rules: reports

Several years after saying the pharmaceutical industry was “getting away with murder,” President Donald Trump appears poised to unveil new drug pricing rules that could shake up U.S. pricing dynamics in a big way. But it remains to be seen exactly how the implementation will play out or whether the incoming Biden administration will keep […]

Iconic buildings and monuments illuminated in blue for World Pneumonia Day

Famous buildings and monuments turned blue this month in a Pfizer-sponsored effort to raise pneumonia awareness. From Trafalgar Bridge in Australia to Niagara Falls in Canada, more than 250 well-known structures in 52 countries were lit up in a brilliant blue hue on Nov. 12. Pfizer collaborated with the Hospital Clinic of Barcelona and the Every Breath Counts Coalition to commemorate World […]