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Pharmaceuticals, health and wellness

AstraZeneca unveils massive $750M deal in effort to produce billions of COVID-19 shots

British drugmaker AstraZeneca has made clear its intent to rapidly scale production of Oxford University’s COVID-19 vaccine hopeful despite a dearth of clinical data to support its use. Now, with an eye-popping deal worth three-quarters of a billion dollars, AstraZeneca is putting its money where its mouth is.  The British pharma has inked a $750 […]

Pfizer, Merck, AZ, J&J and Moderna selected as ‘Warp Speed’ finalists: NYT

The Trump administration has selected its COVID-19 vaccine finalists for Operation Warp Speed, which aims to deliver safe and effective coronavirus vaccines to Americans by the end of the year, The New York Times reports. The finalists—from AstraZeneca, Merck, Pfizer, Johnson & Johnson and Moderna—have a clear Big Pharma slant, with biotechs like Inovio and […]

Drugmakers struggle to meet demand for antidepressant Zoloft amid COVID-19

The COVID-19 pandemic has tested pharma’s supply chain and spawned several drug shortages. Now, with mental health suffering, antidepressant Zoloft and its generics are in short supply. A number of drugmakers are having trouble keeping up with higher demand, while some can’t get their hands on active pharmaceutical ingredients (APIs) to make the medicine, the […]

Emergent BioSolutions, BARDA reach $628M deal to manufacture COVID-19 vaccine hopefuls

The U.S. government has shelled out big money to help develop a possible COVID-19 vaccine and boost manufacturing of COVID-19 drugs stateside. Now, in order to amp up production of its chosen vaccine hopefuls, the government will enlist a Maryland CDMO to get production quickly up to speed. Emergent BioSolutions has won a $628 million […]

ASCO: Has AstraZeneca finally found a place for long-plagued I-O candidate tremelimumab?

AstraZeneca’s CTLA4 candidate tremelimumab has suffered a host of clinical failures that have so far kept it off the market. But new phase 2 results show the company might just be able to use the drug in a new way. Starting previously treated liver cancer patients on a single, 300mg initial dose of tremelimumab and […]

Roche’s Tecentriq gets a green light to challenge Bayer with first-in-class liver cancer nod

After years of having the previously untreated liver cancer market all to itself, Bayer’s Nexavar is getting its first major competition—and it’s coming from Roche’s Tecentriq. The FDA Friday cleared a combination of the checkpoint inhibitor and fellow Roche med Avastin for previously untreated patients with hepatocellular carcinoma, the most common form of the disease. […]

AbbVie scores ‘game-changer’ nod for Oriahnn in uterine fibroids

Most of the recent enthusiasm around AbbVie’s new drugs has centered on immunology meds Skyrizi and Rinvoq, but women’s health med elagolix—known commercially as Orilissa in endometriosis—wants a piece of the spotlight, too. The therapy Friday nabbed an FDA nod to treat heavy menstrual bleeding due to uterine fibroids in pre-menopausal women. Taken alongside estradiol […]

FDA finds likely carcinogen in common diabetes drug metformin. Will recalls follow?

On the hunt for drugs contaminated with a likely carcinogen, the FDA initially tested and cleared generic diabetes med metformin. But now, after an independent lab challenged those findings, the FDA has identified that carcinogen in the widely used med, and broad recalls could be in the offing.  The FDA found carcinogen contamination in extended-release formulations of metformin, […]

Want COVID-19 herd immunity? Get 40% of population vaccinated, says ex-FDA chief Gottlieb

Former FDA Commissioner Scott Gottlieb has a rough estimate for the number of vaccinated people to reach herd immunity for COVID-19. Because about 20% of people may have already been infected by the time a COVID-19 vaccine is launched, “we’d need to get perhaps 40% utilization to achieve herd immunity,” he tweeted Tuesday. How does […]

Sanofi plans to unload a $13B Regeneron stake. Is a rare disease buyout next?

Sanofi and Regeneron unveiled plans last year to restructure their longstanding partnership, and now there are bigger changes afoot, for Sanofi at least: The French drugmaker aims to sell most of its massive stake in its biotech partner. Sanofi detailed plans to unload about 22.8 million Regeneron shares, a stake worth some $13 billion. The sale would put […]

GlaxoSmithKline hands Samsung Biologics $231M to scale up manufacturing

Outside of vaccines, GlaxoSmithKline isn’t a major producer of biologics compared with some of its Big Pharma peers. But it has just signed a big deal to scale up manufacturing in the field. The British pharma tapped South Korean CDMO Samsung Biologics in a deal worth more than $231 million to help it make biologic products […]

FiercePharmaAsia—CanSino’s mRNA coronavirus vaccine; WuXi’s buildup; Fujifilm’s Avigan failure?

CanSino added an mRNA project designed by Precision NanoSystems to its COVID-19 vaccine pipeline. WuXi Biologics finalized a deal to build its first U.S. facility in Worcester, Massachusetts, as WuXi Advanced Therapies launched a new CAR-T cell therapy platform. Fujifilm’s flu drug Avigan reportedly failed in mild and asymptomatic coronavirus patients, but its lead researcher said it’s too […]