News

Sanofi, Regeneron pay $67M for a shortcut in the blockbuster PCSK9 race with Amgen

Sanofi and Regeneron just stole a march on Amgen in the race to get their PCSK9 cardio drug through the FDA and onto the market. The two companies revealed Wednesday evening that they had picked up a priority review voucher BioMarin had won for a recent rare disease drug approval, paying $67.5 million for the regulatory shortcut. They'll split the cost and share in the benefit, shaving four months off the regulatory review time for alirocumab.

Gilead bags a portfolio of HIV-neutralizing antibodies

Gilead has picked up the exclusive rights to develop a set of HIV-neutralizing antibodies discovered at Theraclone in collaboration with the International AIDS Vaccine Initiative and The Scripps Research Institute. Seattle-based Theraclone, which used its tech platform I-STAR in the project, picked up an unspecified set of milestones and an upfront payment in the deal.

Sanofi, Regeneron prep their PCSK9 cardio contender for FDA review after PhIII sweep

Sanofi and Regeneron are heading to the FDA with a potential blockbuster cardiovascular treatment, touting positive results from a slew of Phase III trials in which the drug slashed patients' bad cholesterol.

Immuno-oncology partnering-palooza continues with Genentech, AstraZeneca deals

Demonstrating yet again that AstraZeneca sees a big future for itself in the hot immuno-oncology field, the pharma giant today unveiled another collaboration on a combo for MEDI-4736, its anti-PD-L1 therapy looking to suit up for some blockbuster competition in treating cancer. Japan's Kyowa Hakko Kirin is matching its anti-CCR4 antibody, mogamulizumab, with AstraZeneca's MEDI-4736 to gauge its efficacy and safety in an exploratory Phase I/Ib study. And AstraZeneca will also match its anti-CTLA-4 antibody tremelimumab with Kyowa's drug in a separate combination.

AstraZeneca bets on respiratory growth with $2.1B Almirall deal

AstraZeneca has signed an agreement to pick up Almirall's respiratory business for up to $2.1 billion, hoping to shoulder its way to the front of a blockbuster market for COPD treatments.

Sarepta's boardroom intrigue clouds a promising drug's future

After Sarepta Therapeutics' former head scientist blamed his swift ouster on "serious disagreements" with CEO Chris Garabedian, the company has moved to limit its chief executive's power, according to a report, especially when it comes to meetings with the FDA over the biotech's much-scrutinized lead drug.

UPDATED: Amgen axing up to 2,900 staffers, shuttering R&D campus in revamp

Bracing for an expensive round of late-stage studies and potential drug launches as it ramps up work on a slate of new biosimilars, Amgen reported Tuesday evening that it plans to trim up to 15% of the company's workforce, shutting down facilities in Colorado and Washington state as it slashes up to 2,900 staffers.

Quark's RNAi treatment misses the mark in a Phase II kidney trial

Quark Pharmaceuticals' gene-silencing treatment for kidney transplant complications missed its primary endpoint in a Phase II trial, possibly jeopardizing a deal with Novartis worth up to $680 million.

Merck Serono steps into IO spotlight with PhII cancer study

Looking to share some of the spotlight focused on the immuno-oncology arena, Merck Serono says it has launched a mid-stage study of MSB0010718C, an anti-PD-L1 antibody.

Resurgent Merck to accelerate R&D spending in H2, hunt new drug deals

With investors focused almost exclusively on earnings and R&D programs today, Merck quietly managed to slip in news of a setback in its quarterly report, noting that the FDA has rejected its marketing application for the fertility treatment corifollitropin alfa.

Ex-Pfizer exec Schulman lands at Polaris after an abrupt departure

Months after a swift exit from Pfizer's highest ranks, Amy Schulman has made her next move, joining high-profile biotech investor Polaris as a venture partner

Pfizer, Lilly and J&J chip in on $51M seed fund for New York biotechs

Three Big Pharma companies have helped come up with some seed money to start growing the first crop of biotechs in New York. Pfizer, Eli Lilly and J&J all chipped in to a $51 million fund from Accelerator Corp., which will now expand on the work it's been doing in Seattle to the East Side of Manhattan, recruiting upstarts to join investigators at the Alexandria Center for Life Science.

UPDATED: Targacept's litany of trial failures continues with yet another flop

On Monday, Targacept reported that its midstage effort aimed at salvaging its lead drug flopped. Once partnered with AstraZeneca, which saw four late-stage studies for the one-time depression drug TC-5214 hopeful sour, Targacept says it's finally ready to dump the therapy after it failed in a Phase IIb study for overactive bladder.

Sanofi dumps KaloBios' antibiotic in another stinging setback

KaloBios was an early entrant in 2013's boom of biotech IPOs, touting its development technology as a springboard for high-quality antibodies. A year later, that promise hasn't come to fruition, and partner Sanofi is walking away from an antibacterial program for which the company had high hopes.

AstraZeneca reaches out to Roche with a would-be cancer blockbuster

AstraZeneca has high hopes for the in-development AZD9291, a treatment for lung cancer expected to bring in $3 billion a year at its peak, and the drugmaker is working with rival Roche to craft a blood test that can spot ideal patients for the therapy.

PaxVax nails down $62M to complete vaccine buyout, PhIII study

Redwood City, CA-based PaxVax has nailed down up to $50 million in debt financing and $12 million in a Series B venture funding extension to complete the acquisition of Crucell's oral typhoid vaccine Vivotif and the ongoing Phase III study of its cholera vaccine candidate, PXVX0200.

Zealand inks a $402M cardio-metabolic peptide program with Boehringer

Early this year Zealand Pharma and Boehringer Ingelheim agreed to start over on their three-year-old collaboration to develop a GLP-1 diabetes drug after they decided to part ways on a lead program. Now the Danish biotech will ramp up a second preclinical peptide program with the German pharma company aimed at cardio-metabolic diseases.

The Pfizer dilemma: Spurned by AstraZeneca, revenue falling and facing an R&D crisis

Pfizer is in a nasty fix. Tomorrow the pharma giant will release a rundown of its Q2 numbers--which won't be pretty--and CEO Ian Read and his top team will have plenty of explaining to do about how they plan to get out of the tight spot they find themselves in.

AcelRx shares plunge after FDA rejects its pain drug/device system

Shares of AcelRx took a painful 30% plunge on Monday morning as investors got a chance to respond to the biotech's announcement late Friday night that the FDA had rejected its application for Zalviso, its sufentanil sublingual microtablet drug/device system for fighting pain.

With billionaire's backing, Wyss spinout aims to retire animals in R&D

Over the past 5 years a team at Harvard's Wyss Institute for Biologically Inspired Engineering has been building a pioneering human "organ-on-a-chip" tech platform for discovery-based work on new therapies. And it's being spun out today to make a go of it as an independent company dubbed Emulate Inc., backed with a $12 million A round from a group that includes the billionaire founder of the institute that created the technology.