News

AbbVie mounts a whisper campaign to get Shire on board with its $51.5B offer

Shire has refused to negotiate with a dogged AbbVie after four increasingly priced overtures, and now, with a $51.5 billion offer on the table, AbbVie is pressing shareholders to badger the company into agreeing to a sit-down.

Sanofi's $1.5B dengue vaccine shows Phase III promise, but questions linger

Capping a 20-year effort to develop the world's first dengue fever vaccine, Sanofi has come through with positive results from a sweeping Phase III trial, but its candidate is not quite a panacea for the often deadly disease.

U.K. pols ready for Pfizer's return, AZ cozies up to EU academia, Israeli biotech upsizes IPO

In this week's EuroBiotech Report, no politicians are rushing to Shire's rescue as it attempts to fend off AbbVie, but lawmakers in the United Kingdom are readying their strategies for the next time they do decide to intervene. And more.

Novartis' Enbrel beater nears a soon-to-crowd psoriasis market

Novartis' in-development drug secukinumab beat out the blockbuster Enbrel in improving symptoms of psoriasis in Phase III, improving the company's odds of success in what promises to be a competitive race among next-generation therapies for the autoimmune disease.

Merck vet steps in to lead Third Rock's immuno-oncology upstart

Third Rock Ventures partner Cary Pfeffer is stepping aside as the start-up CEO at Jounce Therapeutics in favor of Merck veteran Richard Murray.

Regado slips again as FDA weighs in on halted cardio trial

The FDA has stamped a full clinical hold on a trial Regado Biosciences had voluntarily paused, shouldering its way into any discussion of resuming the study and sending the biotech's battered shares down further.

Industry Voices: The contributions of immunology translational medicine to clinical pharmaceutical development

Translational medicine, which bridges the science of the emerging preclinical portfolio and the early development space where molecules are studied in humans for the first time, is an important if not essential element of successful pharmaceutical development. 

Shooting for early OK, Sarepta lays out promising 3-year data on Duchenne drug

Coming up on the third anniversary of the Phase IIb trial launch for the Duchenne muscular dystrophy drug eteplirsen, Sarepta Therapeutics says the small group of boys in the study continues to do well, underscoring the company's hopes for gaining an accelerated approval for this treatment.

Bristol-Myers races to the FDA with immuno-oncology star nivolumab

Bristol-Myers Squibb plans to submit its closely watched cancer candidate nivolumab for FDA approval to treat melanoma next quarter, outpacing analysts' expectations and setting the stage for a duel with Merck's rival drug.

Regeneron, Sanofi herald a blockbuster contender with groundbreaking study

If you want to understand why Regeneron R&D chief George Yancopolous gets a king's ransom in annual compensation, you need look no further than the Phase IIb data that has just been posted on dupilumab for severe eczema.

Wall Street wonders what Shire is worth

The share prices of AbbVie and takeover target Shire keep drifting downward amid sustained uncertainty over a deal. A couple of healthcare investors we talked to feel the deal is by no means definite--a concern that is also reflected in the continued wide spread between the latest offer price and Shire's share price.

'Unpromising' Allergan drug projects headed for the chopping block--report

Allergan execs have made no secret of the fact that they've been planning to come up with a lean-and-mean game plan designed to prove to investors that they'd be much better off if they spurned Valeant's offer to buy the company and gut its R&D division. Citing sources close to the company, Bloomberg is reporting that the cutbacks should include work on its most "unpromising" programs in the pipeline.

Sanofi ups the legal ante to block Lilly's Lantus biosimilar

Sanofi has filed another lawsuit against Eli Lilly in hopes of beating back a biosimilar challenge for its top-selling insulin product, claiming its rival's in-development knockoff infringes its intellectual property.

International brouhaha over AbbVie misstep highlights U.K.'s M&A rules

Analysts generally believe that big takeovers are easier to pull off under the U.K.'s M&A guidelines. But you'd better not ignore the very specific rules of the game. AbbVie got a lesson on that score yesterday after CEO Richard Gonzalez confidently confided to a number of major news outlets, including the Financial Times and Reuters, that he had already chatted up most of Shire's big investors and won their support for a $51 billion buyout.

NIH sickle cell partner AesRx moves up the food chain in Baxter buyout

Having played a pioneering role collaborating with the NIH on a new drug for sickle cell disease, Newton, MA-based AesRx has moved up the food chain after completing a buyout deal with Baxter International.

Antibody expert arGEN-X pulls off a $54.5M IPO

Dutch biotech arGEN-X has raised €40 million ($54.5 million) in a Brussels IPO, planning to bankrolling its internal candidates and expand its in-demand antibody technology.

After a taste of disaster, Reata plans a comeback for bardoxolone

Close to four years ago, Reata Pharmaceuticals scored one of the biggest packages of upfront and near-term cash the industry had seen at that point. AbbVie signed up to partner on its chronic kidney drug bardoxolone by dangling $450 million in quick cash, and then came back a year later to get the full portfolio of follow-up drugs at Reata for another $400 million upfront.

Celgene's would-be blockbuster fails in Phase III for spinal arthritis

Celgene's apremilast couldn't quite beat placebo in a late-stage trial on a rare and severe form of arthritis, imperiling a potential indication for a drug the company believes can break the blockbuster barrier.

Otonomy heads to the FDA after its ear treatment clears Phase III

Privately held Otonomy is touting positive late-stage results for its investigational ear treatment, gearing up for an FDA application just months after raising $49 million in venture cash.

Boehringer's 'breakthrough' cancer drug comes through in Phase II

Boehringer Ingelheim's treatment for a rare form of leukemia prolonged survival and beat out chemotherapy in a midstage study on elderly patients, the company said, results that will help make the case for a drug that has already received the FDA's breakthrough therapy designation.