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Pharmaceuticals, health and wellness

Merck’s Keytruda pulled from England’s Cancer Drugs Fund in bladder cancer

Merck’s Keytruda has suffered its second setback with English cost watchdogs in as many months. In final guidance, NICE rejected the drug in patients with locally advanced or metastatic urothelial carcinoma who have had platinum-containing chemotherapy. The drug had been available via England’s Cancer Drugs Fund following an earlier review while authorities collected more evidence. But […]

Look for novel coronavirus treatments first, experts say, and vaccines are farther off than you think

What’s the outlook for really fending off the novel coronavirus? Small molecule drugs and other therapeutics will obviously beat vaccines to market, and Gilead’s remdesivir, if effective, could scale up fast, experts said. Vaccines are likely farther off than quoted timelines suggest. It’s “overly optimistic” to expect them in 12 to 18 months, two opinion leaders […]

Pfizer, Merck KGaA’s Bavencio skewered by Javelin in head and neck cancer

Pfizer and Merck KGaA’s Bavencio threw another Javelin but missed their target in head and neck cancer. Adding Bavencio to chemoradiotherapy didn’t provide much extra benefit to patients with previously untreated locally advanced squamous cell carcinoma of the head and neck, the pair unveiled Friday. The independent data monitoring committee found at an interim analysis that the […]

Regeneron a ‘national strategic asset’ for quick response to COVID-19 outbreak: analyst

Drugmakers of all shapes and sizes are chasing after therapeutics and vaccines to fight the novel coronavirus. But among the pack, one company’s track record might give it the jump on a treatment—and at least one analyst is not afraid to heap praise on its efforts.  Regeneron’s “innovative horsepower and initiative” in its response to COVID-19, including a push to repurpose arthritis med […]

Biogen signs on to manufacture clinical supplies for Vir’s COVID-19 antibodies

Biopharma companies across the globe are scrambling to address the novel coronavirus outbreak, which was declared a pandemic on Wednesday. Now, two of them—Biogen and former CEO George Scangos’ new company, Vir Biotechnology—are teaming up on an antibody development and manufacturing pact. Biogen and Vir have signed a letter of intent and have already started working together. The deal is still subject to final agreements, but due […]

Bristol Myers Squibb snags new liver cancer nod for Opdivo-Yervoy combo

Bristol Myers Squibb’s Opdivo-Yervoy immuno-oncology combo has had some ups and downs lately. But it can now claim a new FDA nod in pretreated liver cancer. The Opdivo-Yervoy regimen is now FDA-approved to treat hepatocellular carcinoma patients who have previously received Bayer’s standard-of-care Nexavar, Bristol said Wednesday. Because the FDA doled out the indication under […]

Takeda’s Ninlaro swings and misses in newly diagnosed myeloma

Just one day after Bristol Myers Squibb said its Empliciti had failed a multiple myeloma trial that could have widened its market, Takeda revealed Ninlaro had suffered the exact same fate. In a study of previously untreated patients ineligible for stem cell transplant, adding Ninlaro to a combination of Celgene’s Revlimid and steroid dexamethasone didn’t […]

Global biopharma supply chain holding together for now: Vertex, Lilly, Recipharm and others update patients 

Biopharma companies are keeping a close eye on supply chains as the COVID-19 epidemic has expanded from China putting production in other countries at risk. So far the backbone of the industry appears to be holding, but not without some strains. As Italy moved to quarantine an area with 16 million people, CDMO Recipharm today […]

Big Pharma grounds employees: GSK, Bristol, Roche, Sanofi and more limit travel due to coronavirus

Biopharma companies are hunkering down as the COVID-19 epidemic breaks out worldwide. In a FiercePharma survey of biopharma companies late last month, most drugmakers said they were simply limiting travel to hard-hit countries such as China, South Korea and Italy. Now, as more cases pop up across the U.S., Europe and Asia, their tone has shifted. GlaxoSmithKline has “instructed all employees […]

AstraZeneca’s Imfinzi records double bladder cancer failure, endangering first nod and dual-IO case

It’s one of those trials that bear some weight: It was meant to confirm a med’s first-ever approval, and industry watchers were looking for clues to assess the chance of future success. But in the case of AstraZeneca’s Imfinzi in bladder cancer, the immunotherapy has failed. On Friday, AstraZeneca said Imfinzi, given alone and in […]

Biogen cracks down on travel after 3 execs test positive for coronavirus

The novel coronavirus has hit home at Biogen, where three executives who traveled to a headquarters management meeting have tested positive for the illness. At last week’s meeting, a “number of attendees reported varying degrees of flu-like symptoms,” the company said in a statement reported in numerous publications. Some have confirmed influenza, while, so far, three […]

Hikma halts production of pain drug because of ‘gelatinous particles’ in vials

Hikma’s U.S. operation has stopped production of an injected pain drug as it figures out how to fix an issue that has resulted in black, oily and gelatinous particles in some vials of the drug. The drugmaker made the disclosure as it extended its recall to the retailer and medical facilities.  The voluntary recall of […]