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Pharmaceuticals, health and wellness

Again? AstraZeneca faces vaccine PR problems as regulators push back on data and pundits shake their heads

Magic Mountain has nothing on the ups and downs of AstraZeneca’s COVID-19 vaccine. The latest? An AstraZeneca press release yesterday touting its U.S. vaccine trial results, followed within hours by a rebuke from U.S. health agencies. The release “may have included outdated information,” the National Institute of Allergy and Infectious Disease said in a middle-of-the-night […]

WuXi Bio, busy building out ex-China production network, taps local CDMO for capacity boost

WuXi Biologics marked 2020 with gung-ho expansions as the China-based CDMO looked to beef up its operations in Europe and the U.S. Now, the company is turning back to its home country with a deal for a homegrown CDMO. WuXi Biologics locked up an agreement to buy more than 90% of CMAB, a Suzhou, China-based CDMO whose services run the gamut from cell-line […]

Merck, Eisai detail Keytruda and Lenvima’s endometrial cancer win in confirmatory study

Merck and Eisai were eager to tout a headline phase 3 win in December for their combination therapy of Keytruda and Lenvima because it involves the regimen’s first FDA-approved indication in endometrial cancer. Now we know how big that win is. Keytruda and Lenvima cut the risk of death by 38% over physician’s choice of […]

Clubhouse for pharma? Maybe not yet, but brands should think about voice identity amid the rise of audio social networks, expert says

Audio channels like Clubhouse, Twitter Spaces, Discord and now Swell are bursting onto the social networking scene, but is there a place for pharma? Yes, says Mark Pappas, who leads growth and innovation at CMI Media Group. While it may be early for pharma brands to jump onto Clubhouse, companies should be thinking ahead and even […]

Incyte, Novartis aim to make Jakafi available in severe COVID-19 after narrow trial miss

Over the span of more than a year during the pandemic, pharma companies of all stripes have tested their existing medicines against COVID-19. Incyte is one of them. Unfortunately, Incyte’s Jakafi fell just short in a phase 3 COVID trial. But now the company and its partner Novartis are determined to forge ahead, saying the […]

Europe endorses AstraZeneca’s COVID-19 vaccine’s safety amid blood clot concerns

After a tough few days for the AstraZeneca COVID-19 vaccine rollout, the European Medicines Agency offered fresh backing for the shot’s safety on Thursday. The regulator reached a “clear scientific conclusion” that the AZ shot is “safe and effective,” EMA executive director Emer Cooke said during a briefing. The protection the shot offers against COVID-19 “outweighs possible risks,” he […]

Pfizer halts biosimilar programs in crowded China market, sells plant to WuXi Biologics

China only approved its first biosimilar drug in 2019, but the market is already looking too crowded for one Big Pharma company. Pfizer has halted its biosimilar programs in China and is selling a biologics facility there to Chinese CDMO giant WuXi Biologics, the company said in a statement Wednesday. The “difficult decision” came after a […]

Challenging AbbVie and Lilly in psoriatic arthritis, J&J touts two-year data for Tremfya

When Johnson & Johnson scored approval for Tremfya in psoriatic arthritis last year, the company set out in crowded field with entrenched competition. But now the drugmaker has new long-term data to bolster its drug’s case. In data from an extended phase 3 trial, more than half of adults on Tremfya achieved complete skin clearance at two years, J&J said. More than 70% of patients achieved […]

Melinta, bouncing back from bankruptcy, lands FDA approval for speedy skin infection fighter

Antibiotic biotechs often struggle to turn their products into commercial triumphs, and that’s certainly been the case for New Haven, Connecticut-based Melinta Therapeutics, which ultimately filed for bankruptcy in late 2019. But Melinta hopes its newly minted drug can become an exception, thanks to a convenience edge over rivals.  The FDA approved Melinta’s Kimyrsa, also known as oritavancin, to treat adults with […]

Pfizer, riding high on COVID-19 vaccine launch, pays CEO Bourla $21 million for 2020

Thanks to the success of its COVID-19 vaccine, the drug giant Pfizer has become a household name around the globe—and the company’s eyeing $15 billion in sales from the shot this year. For writing that 2020 success story, CEO Albert Bourla collected a pay package worth more than $21 million. Bourla, who took the reins […]

Sagent pulls 3 lots of phenylephrine after customer finds a loosely sealed vial

A potential packaging glitch that could compromise sterility has triggered a recall at Sagent Pharmaceuticals. The drugmaker issued a voluntary recall of three lots of injectable phenylephrine hydrochloride, which is used to treat low blood pressure during anesthesia. The recall stemmed from a customer complaint of loose crimped vial overseals, which could result in a non-sterile […]

Europe OKs Johnson & Johnson’s COVID-19 vaccine, but deliveries won’t start till April

Europe’s COVID-19 immunization campaign has been challenged by early supply problems and now safety concerns for AstraZeneca’s shot. A fourth vaccine is now on its way—though it’s not going to fix the supply shortfall immediately. European Commission officials on Thursday endorsed J&J’s coronavirus shot for use in member countries, making the vaccine the first one-dose option to score an […]