10.22.2019

BMS nets another Opdivo lung cancer win—but it still has to beat Merck's high bar

It’s been a rocky road for Bristol-Myers Squibb’s immuno-oncology duo in previously untreated non-small cell lung cancer, but a new addition to the regimen might hold the ticket. Tuesday, the New Jersey drugmaker said its Opdivo-Yervoy duo—plus two cycles of chemo—had lengthened patients’ lives compared with placebo in a phase 3 study.
10.22.2019

Novartis' Zolgensma faces EU, Japan delays after regulators raise 'manufacturing questions'

Novartis’ Zolgensma launch has been anything but boring: First a record-setting price tag, then a data-manipulation scandal and, with Tuesday earnings, a Street-beating first quarter on the market. On top of all that, Novartis is now facing “manufacturing questions” that will delay Zolgensma’s approval in the EU and Japan.
10.22.2019

Sanofi starts on viral vector facility as its R&D focus shifts to gene therapies

Sanofi is playing catch-up in gene therapy, but new CEO Paul Hudson is taking quick steps to close the gap. A reorganization of the R&D unit is intended to pivot the drugmaker toward immuno-oncology drugs and gene therapies. And to hasten the transition, the company is retrofitting a vaccine plant in France into a gene therapy manufacturing operation.
10.22.2019

Biogen's Spinraza is still churning—even after Novartis' rival Zolgensma launch

Biogen's spinal muscular atrophy med Spinraza and Novartis' gene therapy Zolgensma are squaring off in a closely watched market battle, and early numbers indicate the meds might be able to grow sales alongside one another. Spinraza posted consensus-besting sales, with most of its haul coming from outside the U.S.
10.22.2019

Novartis’ Zolgensma beats data woe, as Mayzent hits reimbursement hurdles

Despite initial payer resistance and lingering questions about an FDA crackdown on Novartis after the Zolgensma data manipulation scandal, the costly spinal muscular atrophy gene therapy put up stellar sales Tuesday. But its groundbreaking MS launch Mayzent has hit some unexpected hurdles.
10.21.2019

Vertex lands $6B-plus triple combo nod for CF drug Trikafta—5 months early

The triple combo era in cystic fibrosis is here, thanks to Vertex's new OK. Five months ahead of schedule, the FDA greenlighted Trikafta—the company's next big blockbuster hope—to treat CF patients over the age of 12 with a particular gene mutation.
10.21.2019

J&J, Teva offer a whopping $27B combined to wrap opioid suits, but not all plaintiffs are onboard

Johnson & Johnson and Teva settled with two Ohio counties rather than try the case in court. But that deal was just one piece of a much bigger one in the works: The drugmakers and three distributors are looking to escape all their opioid suits with a settlement valued at $48 billion total. Whether all the plaintiffs agree is an open question.
10.21.2019

J&J's Stelara clinches ulcerative colitis nod to back up declining Remicade

Under assault from newer therapies in the anti-inflammatory market, Johnson & Johnson has focused on expanding Stelara beyond dermatology—and Monday, it took another big step in that direction. The FDA approved Stelara to treat adults with ulcerative colitis, a condition that affects around 910,000 U.S. patients per year.
10.21.2019

Zeroing in on fast-growing vaccines, GSK sheds 2 shots to Bavarian Nordic for up to $1.1B

GlaxoSmithKline's burgeoning vaccines business is selling off two of its smaller shots to focus on its fast-growing top sellers and future prospects in its pipeline. Bavarian Nordic will pick up GSK's rabies and tick-borne encephalitis franchises in a deal that could be worth more than $1 billion.
10.21.2019

AstraZeneca's Farxiga nabs first CV approval from the FDA. Will a bigger one follow?

The Holy Grail for AstraZeneca’s SGLT2 med Farxiga is an approval to treat heart failure in patients with or without diabetes—and it’s well on its way to that goal. But while it waits for that game-changing win, Farxiga will take a heart-helping approval for diabetes patients.