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Pharmaceuticals, health and wellness

Chasing GW’s Epidiolex, Zogenix finally wins FDA nod for rare childhood epilepsy drug Fintepla

Zogenix has its first commercial product, a rare childhood epilepsy drug that could challenge GW Pharmaceuticals’ blockbuster hopeful Epidiolex. On Thursday, the FDA approved Zogenix’s Fintepla to treat seizures associated with Dravet syndrome, a potentially life-threatening form of epilepsy, in patients 2 years of age and older. The company’s commercial team has prepared a slate of […]

Novartis inks settlements worth $347M with DOJ, SEC over foreign doctor payments, records keeping

Novartis has faced years of investigations into its overseas conduct, including kickbacks probes in Greece and South Korea. Now, it’s admitting it paid doctors to use more of its products in certain countries—and agreed to pay $347 million for violating the U.S. Foreign Corrupt Practices Act. The company will shell out $234 million to the Department of Justice and […]

Merck treads on Sanofi, Regeneron’s turf with Keytruda’s latest skin cancer OK

It’s a feeling Sanofi and Regeneron’s immuno-oncology rivals know all too well: Merck & Co.’s Keytruda just moved into a market you had cornered. Now, the pair is about to get its first taste of that particular brand of competition. The FDA Wednesday approved Keytruda in recurrent or metastatic cutaneous squamous cell carcinoma that can’t be […]

Judges slam J&J’s ‘reprehensible’ talc defense, cut massive 2018 verdict to $2.11B

For years, Johnson & Johnson has vowed to appeal each talc verdict it lost, and the company cited a “fundamentally unfair process” and “multiple errors” when jurors in St. Louis ordered the company to pay $4.69 billion to 22 women with ovarian cancer.  Now, an appeals court has reduced that award—but only to $2.11 billion, thanks to J&J’s “outrageous” and “reprehensible” defense of the product. J&J brought […]

Mylan, looking to capitalize on Biogen’s Tecfidera patent loss, faces fork in the road on generic launch

Biogen took a major hit last week when a federal court tossed out its patent protections for multiple sclerosis drug Tecfidera. That loss could be Mylan’s gain—but it would require the Pennsylvania generics maker to chance an “at-risk” launch, one analyst says. While Biogen appeals the West Virginia federal court ruling, Mylan could have a […]

Pfizer’s blockbuster-to-be Vyndaqel is too costly for heart patients, study suggests

Pfizer’s tafamidis arrived in the U.S. in 2019 with a vastly discounted list price over rival transthyretin amyloidosis drugs. But its $225,000-a-year tag still seems too much for many heart patients. Previous cost-effectiveness analyses and physicians themselves have warned tafamidis is too pricey—the world’s most expensive medication for cardiovascular disease, to be exact. And now, a […]

GlaxoSmithKline recalls children’s Robitussin, Dimetapp with faulty dosing cups

British drugmaker GlaxoSmithKline was one of many companies forced to pull its version of heartburn med Zantac off shelves last year after a widespread carcinogen scare. Now, GSK is in hot water for other popular over-the-counter meds, but this time it could affect children. GSK has voluntarily recalled multiple lots of Children’s Robitussin Honey Cough […]

FiercePharmaAsia—Sinopharm, Sinovac COVID vaccines; Takeda’s warning letter, $2B pipeline cull

China’s Sinopharm and Sinovac reported positive midstage clinical results for their inactivated COVID-19 vaccines, just as Clover Biopharmaceuticals entered the clinic with its subunit vaccine with help from adjuvants by GlaxoSmithKline and Dynavax. A Takeda plant in Japan was slapped with an FDA warning letter, and the company is sending off seven neuroscience assets to Neurocrine […]

Ultragenyx’s Crysvita scores FDA nod in 2nd ultra-rare bone disorder

Ultragenyx and Kyowa Kirin raised eyebrows when they launched ultra-rare disease Crysvita in 2018 with an eye-popping price tag of $200,000 per year. Despite some pushback from cost watchdogs, the partners kept pushing to expand Crysvita’s reach and now have the FDA’s green light in a second indication. The FDA on Thursday approved Crysvita to […]

Lilly touts Emgality’s ability to reduce migraine patients’ overall pain in first look at ‘holistic approach’

Eli Lilly is facing off against Amgen, Teva and Lundbeck in the competitive field of CGRP migraine prevention drugs, and the drugmaker is now touting data showing that its Emgality can reduce total pain burden for patients, a class first.  In three randomized studies, episodic migraine patients on Emgality experienced 68.6 fewer hours of severity-weighted pain per month on average, compared with 36.2 for placebo, Lilly said Tuesday.  The reduction was bigger for patients with chronic migraine. Those […]

U.K. endorses dexamethasone in COVID-19 hours after groundbreaking data release

Right on the heels of data showing the decades-old, inexpensive steroid dexamethasone can reduce COVID-19 deaths among hospitalized patients requiring oxygen, the U.K. government granted a world-first approval.  The nod, in COVID-19 patients who are hospitalized and requiring oxygen, including those on ventilators, came hours after government-funded research proved the drug reduced risk of death by 35% for patients on ventilators […]

Gilead sees better days ahead for CAR-T therapy Yescarta with Amsterdam manufacturing hub online

Like all drugmakers with CAR-T cell therapies on the market, Gilead Sciences has had its fair share of roadblocks to commercial success––not the least of which has been a difficult manufacturing scale-up. Now, Gilead could be ready to take CAR-T therapy Yescarta to the next level with a long-awaited European production hub.  After years in the works, Gilead’s 117,000-square-foot CAR-T facility […]