Shares of Adamis crater on CRL; Boris John­son promis­es to dou­ble de­men­tia re­search fund­ing

→ San Diego-based Adamis $ADMP saw its shares crater on the news that the FDA has re­ject­ed its ap­pli­ca­tion to mar­ket high-dose nalox­one in­jec­tion for the treat­ment of opi­oid over­dose. The stock dropped about 50%, falling deep in­to pen­ny stock ter­ri­to­ry. Ac­cord­ing to the biotech, the FDA had some out­stand­ing ques­tions on CMC that have to be re­solved ahead of any ap­proval.

→ Af­ter re­cent­ly pledg­ing £250 mil­lion in­to AI adop­tion in the NHS, UK Prime Min­is­ter Boris John­son vowed in his man­i­festo un­veiled on Sun­day to in­vest an ad­di­tion­al £83 mil­lion a year in­to de­men­tia re­search, dou­bling cur­rent fund­ing, over the next decade if the Con­ser­v­a­tive Par­ty pre­vails in the gen­er­al elec­tion. In ad­di­tion, the To­ries al­so promised to cre­ate a new £500 mil­lion fund for new med­i­cines treat­ing hard to cure dis­eases such as can­cer.

Sor­ren­to Ther­a­peu­tics re­vealed to­day that it has re­ject­ed an un­so­licit­ed buy­out pro­pos­al from two phar­ma­ceu­ti­cal com­pa­nies. At a range of $3 to $5 per share in cash, re­spec­tive­ly, the com­pa­ny said it was “sig­nif­i­cant­ly un­der­val­ued” by the suit­ors and a deal “was not in the best in­ter­ests of its share­hold­ers.” Ac­cord­ing to Reuters, Sor­ren­to would have been val­ued $709.4 mil­lion at the high­er end of the of­fer — while mar­ket cap­i­tal­iza­tion sits be­low $227 mil­lion. The San Diego-based biotech, which has inked deals with Yuhan, Servi­er and Nant­Phar­ma over the years, added that it be­lieves that its pend­ing li­cens­ing and col­lab­o­ra­tion trans­ac­tions would cre­ate val­ue ex­ceed­ing the pro­pos­al.

→ Af­ter snag­ging FDA ap­proval for its nasal spray Nayzil­am (mi­da­zo­lam) — said to be the first nasal ther­a­py avail­able for seizure clus­ters — back in May, UCB says that the ther­a­py will be avail­able in re­tail phar­ma­cies on De­cem­ber 2, 2019 for the treat­ment of seizure clus­ters that are dis­tinct from a pa­tient’s usu­al seizure pat­tern in those with epilep­sy 12 years of age and old­er.

→ Phar­ma ser­vice com­pa­ny In­cep­tua Group has inked an ex­clu­sive clin­i­cal tri­al sup­ply agree­ment for on­col­o­gy gener­ics with Ger­man man­u­fac­tur­er Ben­dalis. Un­der the agree­ment, In­cep­tua will be­come the ex­clu­sive dis­trib­u­tor of Ben­dalis’ prod­ucts for their use in clin­i­cal tri­als world­wide.

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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