Soon af­ter word got out about an FBI probe in­to uBio­me’s billing prac­tices, the mi­cro­bio­me test­ing start­up put its gen­er­al coun­sel in charge as the co-founders stepped aside from their roles as co-CEOs. John Rakow, the in­ter­im CEO, vowed to “co­op­er­ate ful­ly with gov­ern­ment au­thor­i­ties and pri­vate pay­ors to sat­is­fac­to­ri­ly re­solve the ques­tions that have been raised.”

John Rakow uBio­me

Turns out that was not good enough.

The San Fran­cis­co-based com­pa­ny is now in­stalling new lead­er­ship from the con­sult­ing firm Goldin As­so­ci­ates to re­place Rakow two months af­ter he was first ap­point­ed, the Wall Street Jour­nal re­port­ed. The new, in­ter­im man­age­ment team con­sists of CEO Cur­tis Solsvig, CFO Robin Chu and COO Karthik Bhavara­ju. The turn­around ex­perts from Goldin have been work­ing with uBio­me for the last month.

In ad­di­tion, Jes­si­ca Rich­man and Zach Apte — the co-founders — are turn­ing their sus­pen­sion to a full-on res­ig­na­tion from the com­pa­ny’s board, ac­cord­ing to an in­vestor let­ter re­viewed by the Jour­nal.

Rich­man and Apte launched uBio­me 6 years ago af­ter rais­ing $350,000 from a crowd­fund­ing cam­paign. It has since scored VC back­ing to­tal­ing $83 mil­lion from Y Com­bi­na­tor, An­dreessen Horowitz, 8VC and oth­ers as well as aca­d­e­m­ic part­ner­ships with the likes of UCSF and Har­vard. The biotech al­so boost­ed its pro­file by re­cruit­ing star di­rec­tors to its board, in­clud­ing ex-No­var­tis CEO Joe Jiminez, whom it said would con­tribute ex­per­tise for a piv­ot to the drug busi­ness.

Cur­tis Solsvig Goldin

The ex­ecs fol­lowed up their ini­tial con­sumer test, Ex­plor­er, with more tar­get­ed tests de­signed to eval­u­ate gut health, vagi­nal health and the mi­crobes that may be im­pli­cat­ed in pa­tients’ flu symp­toms. SmartGut and Smart­Jane were pulled from the mar­ket in May af­ter the FBI searched uBio­me’s of­fice — though the com­pa­ny didn’t spec­i­fy the rea­son.

In­sid­ers lat­er told the Jour­nal that in­sur­ers had large­ly stopped pay­ing for the tests as uBio­me was sus­pect­ed of us­ing im­prop­er billing codes and charg­ing for un­nec­es­sary tests.

The de­ci­sion to put new lead­ers in place re­port­ed­ly came from a spe­cial board com­mit­tee that was formed in the wake of the FDA raid to con­duct an in­ter­nal in­ves­ti­ga­tion.

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.