On the same day that Glax­o­SmithK­line sought to as­sure in­vestors that the com­pa­ny’s new R&D team would de­liv­er im­por­tant drugs in the fu­ture, its re­searchers work­ing on Nu­cala (mepolizum­ab) were slapped down in their at­tempt to gain an added OK for COPD.

A pan­el of out­side ex­perts vot­ed 16 to 3 against a mar­ket­ing ap­proval. That isn’t bind­ing, but af­ter the in­ter­nal re­view­ers at the FDA of­fered a scathing re­view of their da­ta, it’s all but a done deal now — bar­ring some un­ex­pect­ed last minute in­ter­ven­tion in its fa­vor.

AD­COMM VOTE: Is the ben­e­fit-risk pro­file ad­e­quate to sup­port ap­proval of #mepolizum­ab as add-on treat­ment to in­haled cor­ti­cos­teroid-based main­te­nance treat­ment for the re­duc­tion of ex­ac­er­ba­tions in pa­tients with #COPD guid­ed by blood eosinophil counts? $GSK
3-Yes
16-No
0-Ab­stain

— SAC Track­er (@FDAad­comm) Ju­ly 25, 2018

The FDA was clear­ly unim­pressed with GSK’s pack­age.

GSK’s drug failed one late-stage test while scor­ing a suc­cess in the oth­er. With on­ly two Phase III stud­ies in this in­di­ca­tion, that left the pan­el to con­sid­er an ap­proval with­out sup­port­ing da­ta from two well-con­trolled stud­ies — the agency gold stan­dard.

There was no dose re­sponse they could find in the two dosage arms, which didn’t help.

The FDA added:

Some key sec­ondary end­points, such as time to first mod­er­ate-to-se­vere COPD ex­ac­er­ba­tion showed nu­mer­i­cal trends fa­vor­ing mepolizum­ab. How­ev­er, there were no con­sis­tent and clin­i­cal­ly mean­ing­ful dif­fer­ences in se­vere COPD ex­ac­er­ba­tion rate, FEV1, or SGRQ be­tween mepolizum­ab 100 mg and place­bo.

GSK’s tri­al de­sign al­so spurred ques­tions, with no base­line col­lec­tion of asth­ma his­to­ry — which could have in­flu­enced the out­come of the study. How will GSK prop­er­ly de­fine the pa­tient pop­u­la­tion for this drug?

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.