SR One leads $55M round for nasal al­ter­na­tive to EpiPen; Sanofi pulls web­site over ac­cu­ra­cy con­cerns

Cal­i­for­nia-based bio­phar­ma com­pa­ny ARS Phar­ma­ceu­ti­cals said to­day that they have closed on a Se­ries D round of $55 mil­lion. The round was led by SR One, with RA Cap­i­tal Man­age­ment and Deer­field Man­age­ment par­tic­i­pat­ing.

ARS is us­ing the mon­ey to ad­vance its drug Neffy, an ep­i­neph­rine nasal spray, through FDA ap­proval and ini­tial launch to con­sumers as an easy-to-use al­ter­na­tive to EpiPen for se­vere al­ler­gic re­ac­tions.

Pe­ter Kolchin­sky

“ARS is very pleased to have gained the sup­port of a top-tier group of in­vestors … This ad­di­tion­al fund­ing will al­low us to fo­cus on pre-launch ac­tiv­i­ties for Neffy and ad­di­tion­al re­search and de­vel­op­ment for a sec­ond in­di­ca­tion for nasal ep­i­neph­rine that we be­lieve can add sig­nif­i­cant val­ue to the ARS port­fo­lio,” ARS founder, CEO and pres­i­dent Richard Lowen­thal said in a state­ment.

Ad­di­tion­al­ly, ARS ap­point­ed Ra­jeev Dadoo, man­ag­ing part­ner of SR One, and RA Cap­i­tal’s Pe­ter Kolchin­sky to the board of di­rec­tors. This comes on the heels of ARS adding ex-Al­ler­gan CEO Brent Saun­ders to their board of di­rec­tors ear­li­er this year, just a week af­ter Saun­ders be­came chair­man of OcuTer­ra, a small Boston-based biotech com­pa­ny.

Sanofi pulls val­proate web­site over ac­cu­ra­cy con­cerns

The UK’s Med­i­cine and Health­care prod­ucts Reg­u­la­to­ry Agency reached out to Sanofi over con­cerns that a web­site was not up to date on safe­ty con­cerns for val­proate, a drug that Sanofi holds mar­ket au­tho­riza­tion for in the UK. The web­site was pulled down in its en­tire­ty.

Ac­cord­ing to an an­nounce­ment made by the agency, a mem­ber of the pub­lic con­tact­ed MHRA to raise con­cerns about a web­site called the Val­proate Knowl­edge Cen­tre, a Sanofi web­site de­signed for health­care pro­fes­sion­als. They were con­cerned that da­ta on the web­site were se­lec­tive in na­ture and that the im­por­tance of some of the in­for­ma­tion felt ei­ther min­i­mized or lack­ing in ad­vice or de­tail. The com­plainant al­so said that pa­tients were eas­i­ly able to ac­cess an area for doc­tors on­ly, and that it was not clear that the web­site was a Sanofi web­site from the web ad­dress.

In light of this, MHRA con­tact­ed Sanofi re­gard­ing the con­cerns and asked them to re­view their web­site — in­clud­ing to en­sure it was up to date to sup­port safe use of val­proate. Sanofi then de­cid­ed to take down the web­site, as safe­ty in­for­ma­tion was avail­able else­where on­line. No fur­ther ac­tion was tak­en by MHRA.

At the In­flec­tion Point for the Next Gen­er­a­tion of Can­cer Im­munother­a­py

While oncology researchers have long pursued the potential of cellular immunotherapies for the treatment of cancer, it was unclear whether these therapies would ever reach patients due to the complexity of manufacturing and costs of development. Fortunately, the recent successful development and regulatory approval of chimeric antigen receptor-engineered T (CAR-T) cells have demonstrated the significant benefit of these therapies to patients.

All about Omi­cron; We need more Covid an­tivi­rals; GSK snags Pfiz­er’s vac­cine ex­ec; Janet Wood­cock’s fu­ture at FDA; and more

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Biospec­i­men M&A: Dis­cov­ery ac­quires Al­bert Li's he­pa­to­cyte project; PhI­II tri­al on Bay­er's Nube­qa reached pri­ma­ry end­point

Discovery Life Sciences has acquired what claims to be the Maryland-based host of the world’s largest hepatocyte inventory, known as IVAL, to help researchers select more effective and safer drug candidates in the future.

The combined companies will now serve a wider range of drug research and development scientists, according to Albert Li, who founded IVAL in 2004 and is set to join the Discovery leadership team as the CSO of pharmacology and toxicology.

Usama Malik

Ex-Im­munomedics CFO charged with in­sid­er trad­ing, faces up to 20 years in prison af­ter al­leged­ly tip­ping off girl­friend and rel­a­tives of a PhI­II suc­cess

The former CFO of Immunomedics, who helped steer the company to its $21 billion buyout by Gilead last year, has been charged with insider trading, the Department of Justice announced Thursday.

Usama Malik tipped off his then-girlfriend and four others that a Phase III study for Trodelvy would be stopped early four days before Immunomedics publicly announced the result in April 2020, DoJ alleged in its complaint. The individuals then purchased Immunomedics shares, selling them after the news broke and Immunomedics’ stock price doubled.

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Merck's new antiviral molnupiravir (Quality Stock Arts / Shutterstock)

As Omi­cron spread looms, oral an­tivi­rals ap­pear to be one of the best de­fens­es — now we just need more

After South African scientists reported a new Covid-19 variant — dubbed Omicron by the WHO — scientists became concerned about how effective vaccines and monoclonal antibodies might be against it, which has more than 30 mutations in the spike protein.

“I think it is super worrisome,” Dartmouth professor and Adagio co-founder and CEO Tillman Gerngross told Endpoints News this weekend. Moderna CEO Stéphane Bancel echoed similar concerns, telling the Financial Times that experts warned him, “This is not going to be good.”

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Ab­b­Vie tacks on a new warn­ing to Rin­voq la­bel as safe­ty frets crimp JAK class

The safety problems that continue to plague the JAK class as new data highlight some severe side effects are casting a large shadow over AbbVie’s Rinvoq.

As a result of a recent readout highlighting major adverse cardiac events (MACE), malignancy, mortality and thrombosis with Xeljanz a couple of months ago, AbbVie put out a notice late Friday afternoon that it is adding the new class risks to its label for their rival drug.

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Pfiz­er, Am­gen and Janssen seek fur­ther clar­i­ty on FDA's new ben­e­fit-risk guid­ance

Three top biopharma companies are seeking more details from the FDA on how the agency conducts its benefit-risk assessments for new drugs and biologics.

While Pfizer, Amgen and Janssen praised the agency for further spelling out its thinking on the subject in a new draft guidance, including a discussion of patient experience data as part of the assessment, the companies said the FDA could’ve included more specifics in the 20-page draft document.

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Re­searchers move clos­er to de­ci­pher­ing blood clots from As­traZeneca, J&J's Covid-19 vac­cines

Researchers may be nearing an answer for the mysterious and life-threatening blood clots that appeared on very rare occasions in people who received the J&J or AstraZeneca Covid-19 vaccine.

The new work builds on an early hypothesis researchers in Norway put forward last spring, when the cases first cropped up. They proposed the events were similar to blood clots that can occur in a small subset of patients who receive heparin, one of the most commonly used blood thinners.

Janet Woodcock (AP Images)

Janet Wood­cock plots her fu­ture at FDA, with se­nior ad­vi­sor role to fall back on if Califf wins con­fir­ma­tion

Acting FDA commissioner Janet Woodcock has been the face of just about every drug approval decision at the agency since the turn of the century. Since the pandemic began, she’s moved between the top of the drugs center to the head of therapeutics at Operation Warp Speed, leading the drive for work on Covid-targeted mAbs and antivirals.

Looking forward — and pending a quick Senate confirmation to cement Rob Califf’s return to the top of FDA early next year — Woodcock’s role at the agency will again be in flux.

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