News

Data in hand, Merck shoots for Keytruda approval for lung cancer

Hot on the heels of Bristol-Myers Squibb, Merck announced over the weekend that it has filed for FDA approval to market its PD-1 star Keytruda for non-small cell lung cancer.

Biotech guru Neil Woodford lands $1.2B for new tech fund

U.K. investment guru Neil Woodford has landed his $1.2 billion tech fund, making it a record debut for an investment trust in the country.

Lilly's psoriatic arthritis drug aces Phase III with a crowded market ahead

Eli Lilly's closely watched autoimmune treatment met its main goals in a Phase III psoriatic arthritis trial, rolling toward an FDA application and a shot at competing in a fast-crowding space.

Ampio routed as lead osteoarthritis drug flunks a PhIII test

Shares of Ampio Pharmaceuticals were crushed this morning after the biotech acknowledged that its lead drug flunked a Phase III test for osteoarthritis. And the news comes just days after one of its drug subsidiaries was absorbed into a new biotech that will be called Aytu.

Novartis' new CAR-T hopeful looks safe in an early solid tumor study

A novel immuno-oncology treatment from Novartis and the University of Pennsylvania came through in an early safety study on patients with solid tumors, encouraging investigators and burnishing its potential.

Roche bets $555M on an Indian biotech's immuno-oncology drug

Roche inked a deal worth up to $555 million to work with India's Curadev Pharma on cancer treatments that use the body's immune system to combat tumors, expanding its trove of assets in one of the industry's hottest fields.

What's driving the massive social media campaign for Genervon's ALS drug?

Genervon CEO Winston Ko has repeatedly prodded a desperate ALS patient population and their families to demand that the FDA provide an accelerated approval to allow sales of its controversial drug based on the data from 8 patients in one tiny study.

Sanofi and Innate Pharma team up on anticancer ADCs

Sanofi has reached out to its French neighbor Innate Pharma to collaborate on armed antibody treatments, borrowing the biotech's technology to craft new treatments for cancer and inflammatory disease.

Takeda inks a $270M stem cell deal with Kyoto University

Takeda has struck up a 10-year partnership with Japan's Kyoto University to develop potential stem cell treatments for an array of diseases, committing about $270 million to the effort.

UPDATED: The FDA challenges Genervon to release data from controversial ALS study

Yesterday, FierceBiotech reported how an expert review of a tiny study for Genervon's ALS drug GM604 had raised serious questions about the data that were provided by the company, which has aroused a furious campaign by ALS sufferers to gain an accelerated FDA approval. Today, in a rare break from the agency's standard "no comment" approach to experimental drugs, the agency called on the biotech to come clean and publicly release the actual results.

AstraZeneca's '$3B' lung cancer drug impresses in a Phase II race with Clovis

AstraZeneca's in-development lung cancer pill extended progression-free survival by more than a year in new Phase II data, a positive sign for a drug the company believes can bring in $3 billion in annual sales at its peak.

Drew Fromkin tapped to lead Langer's Blend Therapeutics

Welcome to this week's Chutes and Ladders, our roundup of hirings and retirings throughout the industry. Please send the good word--or the bad--from your shop to Eric Sagonowsky (email) or...

Athersys tanks as its stem cell therapy flunks a Phase II stroke trial

Athersys' in-development stem cell treatment failed to beat placebo in a Phase II trial on stroke patients, demolishing the company's value as management digs for a positive spin.

Biotech venture investing continues to sizzle in a big, $1.7B Q1

With crossover investors still crowding into the biotech field to help launch a wave of new IPOs, the industry recorded $1.7 billion in new venture funds in the first quarter, according to The MoneyTree Report by PricewaterhouseCoopers and the National Venture Capital Association based on data from Thomson Reuters.

Atlas Venture unveils a $280M pure play biotech startup fund

Atlas Venture is unveiling a new $280 million fund today that will double down on its bet on cutting-edge drugs. Atlas relied on two close industry giants--Amgen and Novartis--and a mix of old and new investors to help raise a fund that easily broke through its $250 million cap.

Israel awaits $250M fund, ThromboGenics spins out oncology asset, MolMed licenses CAR-T

In this week's EuroBiotech Report, OrbiMed Advisors is in the early stages of preparing a second Israel-focused fund that could transfer $250 million (€235 million) from the pockets of investors into the bank accounts of local life science players. And more.

Medicines Co.'s cangrelor finally lines up for FDA approval

A panel of FDA advisers reversed its earlier derision and voted in favor of The Medicines Company's long-delayed blood thinner, spelling a likely approval for the drug after years of setbacks.

Actelion launches Phase III MS test for ponesimod

Buoyed by the success of its PAH franchise, Switzerland's Actelion says it has begun a Phase III study of its in-house drug ponesimod for multiple sclerosis.

MolMed picks up CAR-T asset from hot Italian research institute

MolMed has become the latest to buy its way into the CAR-T race. The deal sees it pick up assets from an immune-gene therapy CAR-CD44v6 project run by a group at San Raffaele Scientific Institute, the Milan-based research center that struck a deal with Biogen in January.

Galapagos rolls the dice on a $150M IPO, gambling on rheumatoid arthritis drug

A day after Galapagos rolled out promising results for its oral rheumatoid arthritis drug filgotinib on Tuesday, the Belgian biotech confidently rolled out its plan to raise $150 million in an IPO on Nasdaq. And with topline results for a follow-up study expected in a matter of days, Galapagos says it should be poised to jump into Phase III with a $200 million licensing deal from AbbVie expected before the end of this year.