For 13 years, the Cana­di­an biotech Cor­re­vio tried to get the FDA to ac­cept a heart drug since aban­doned by Mer­ck and Astel­las. Yes­ter­day, the agency’s out­side ex­perts vot­ed 11-2 against ap­proval, all but as­sur­ing an­oth­er re­jec­tion for the atri­al fib­ril­la­tion com­pound ver­nakalant.

Mark Cor­ri­g­an

And to­day Cor­re­vio an­nounced that Cor­re­vio may soon be no more. The com­pa­ny said it is look­ing to sell it­self as its stock plum­mets in­to pen­ny-stock ter­ri­to­ry $CORV and its po­ten­tial mon­ey­mak­er sput­ters once more.

“It is in the best in­ter­est of our stake­hold­ers to ex­pand our in­ter­nal cor­po­rate de­vel­op­ment ef­forts and for­mal­ly eval­u­ate strate­gic al­ter­na­tives for the com­pa­ny,” CEO Mark Cor­ri­g­an said in state­ment.

Ver­nakalant could have made Cor­re­vio up to $150 mil­lion per year if ap­proved, ac­cord­ing to Bloom Bur­ton an­a­lyst David Mar­tin. Then known as Car­diome, the biotech had first tried to get the drug ap­proved in 2006. When the FDA re­ject­ed them in 2008, they planned an­oth­er Phase III tri­al.

That Phase III came to a halt when the FDA slapped a hold over a pa­tient death, bur­nish­ing safe­ty con­cerns that prompt­ed the first re­jec­tion and were front and cen­ter in yes­ter­day’s FDA out­side re­view.

The drug is ap­proved in Eu­rope, Cana­da and oth­er coun­tries. Even with sales from that and oth­er drugs, in­clud­ing two an­tibi­otics, Cor­re­vio post­ed $10.8 mil­lion in loss­es last quar­ter.

By Mwango Kashoki, MD, MPH, Vice President-Technical, and Richard Macaulay, Senior Director, of Parexel Regulatory & Access

In recent years, we’ve seen a significant uptake in the use of regulatory options by companies looking to accelerate the journey of life-saving drugs to market. In 2018, 73% of the novel drugs approved by the U.S. Federal Drug Administration (FDA) were designated under one or more expedited development program categories (Fast Track, Breakthrough Therapy, Priority Review, and Accelerated Approval).ᶦ

As the world becomes increasingly dependant on Asia for the ingredients of its medicines, Sanofi sees business to be done in Europe.

The French drugmaker said it’s creating the world’s second largest active pharmaceutical ingredients (API) manufacturer by spinning out its six current sites into a standalone company: Brindisi (Italy), Frankfurt Chemistry (Germany), Haverhill (UK), St Aubin les Elbeuf (France), Újpest (Hungary) and Vertolaye (France). They have mapped out €1 billion in expected sales by 2022 and 3,100 employees for the new operations headquartered in France.

SoftBank has found its newest biotech investment.

The Japanese bank has invested $165 million into Karius, a company that uses blood tests to diagnose infectious diseases, as part of its new Vision Fund 2. The full scope of the new fund has yet to be announced, but the first and newly-beleaguered Vision Fund poured $100 billion into technology companies, including the biotechs Vir Biotechnology and Roivant and the sequencing company 10x Genomics.

An experimental drug that promises to be the first anti-infective agent to prove superior to vancomycin — an antibiotic approved in 1958 — has notched the FDA’s “breakthrough” status.

ContraFect said the designation was based on Phase II data in which exebacase was tested against a superbug known as methicillin-resistant Staph aureus, or MRSA. In a subgroup analysis, the clinical responder rate at day 14 was 42.8% higher than that among those treated with standard of care, the company said (p=0.010).

For two months, as the novel coronavirus swelled from a few early cases tied to a Wuhan market to a global epidemic, most of the world’s focus and dollars have flowed toward emergency initiatives: building vaccines at a record pace, plucking experimental antivirals out of freezers to see what sticks and immunizing mice for new antibodies.

Now a new and well-funded collaboration between Harvard and a top Chinese research institute will play the long game. In a 5-year, $115 million initiative backed by China Evergrande Group, researchers from the Harvard Medical School, Harvard T.H. Chan School of Public Health and Guangzhou Institute for Respiratory Health will study the virus in an effort to develop therapies against infections by the novel coronavirus, known as SARS–CoV-2, and to prevent new ones.

Zoetis forked over $85 million in 2017 to acquire Nexvet Biopharma and its pipeline of monoclonal antibodies. Juergen Horn, Nexvet’s former chief product development officer, has now secured $15 million for his own biologic company for animals: Invetx.

Buoyed by emerging advances in gene therapies for humans, scientists have started looking at harnessing the technology for animals setting up companies such as Penn-partnered Scout Bio and George Church-founded Rejuvenate Bio. But akin to Nexvet, Invetx is working on leveraging the time-tested science of monoclonal antibodies to treat chronic diseases that afflict man’s best friend.

As the coronavirus originating out of Wuhan spreads to South Korea, Italy and Iran, stoking already intense fears of a pandemic, GlaxoSmithKline has found another pair of trusted hands to place its adjuvant system. China’s Clover Biopharmaceuticals will add the adjuvant to its preclinical, protein-based vaccine candidate against SARS-CoV-2.

Clover, which is based in the inland city of Chengdu, boasts of a platform dubbed Trimer-Tag that produces covalently-trimerized fusion proteins. Its candidate, COVID-19 S-Trimer, resembles the viral spike (S)-protein found in the virus.