Star drugs like BM­S' Op­di­vo, As­traZeneca's Lyn­parza will get speedy OKs in Chi­na this year, new re­port pre­dicts

Now that Chi­na has re­vamped its drug re­view process to speed things up for de­vel­op­ers, a new re­port pre­dicts that Bris­tol-My­ers Squibb $BMY, As­traZeneca $AZN and Am­gen $AMGN are among the lead­ing multi­na­tion­al phar­ma gi­ants that will win ap­proval for some block­buster hope­fuls. Oth­ers stand to ben­e­fit from mar­ket­ing drugs de­vel­oped by Chi­nese part­ners.

The re­port, pro­duced by Bei­jing-based da­ta provider Pharm­Cube, high­lights 16 prod­ucts Chi­nese reg­u­la­tors are ex­pect­ed to green light in 2018. Over half of them in­volve an over­seas play­er in bio­phar­ma.

The re­port came out just ahead of the CF­DA’s up­dat­ed set of guide­lines for a pri­or­i­ty re­view path­way, con­tin­u­ing an em­pha­sis on speed­ing re­views and new drug ap­provals spot­light­ed through­out last year. Com­pa­nies can now seek pri­or­i­ty re­view of drug can­di­dates that meet one of a list of cri­te­ria, or prove ef­fec­tive in treat­ing sev­er­al ma­jor dis­eases. And a host of key out­fits are rush­ing in to see how they can be­gin to cap­i­tal­ize on the boom­ing Chi­nese health care mar­ket.

On track to be Chi­na’s first PD-1/PD-L1 check­point treat­ment, BMS’ Op­di­vo (nivolum­ab) is high up on the list. The ap­pli­ca­tion was ac­cept­ed in No­vem­ber and grant­ed pri­or­i­ty re­view in De­cem­ber. The hopes for a speedy ap­proval is high giv­en its clin­i­cal ben­e­fits and the at­ten­tion it has gar­nered (not to men­tion that the bi­o­log­ic queue is rel­a­tive­ly short). Con­sid­er­ing As­traZeneca’s lung can­cer drug Tagris­so was OK’d with­in three weeks of get­ting ac­cel­er­at­ed re­view, a Q1 ap­proval does not seem far-fetched.

As­traZeneca is cheer­ing on its own Lyn­parza for ovar­i­an can­cer, which was the first im­port­ed drug to in­clude in­ter­na­tion­al mul­ti­cen­ter da­ta in its ap­pli­ca­tion. Pharm­Cube is look­ing at a Q3 ap­proval for this one, giv­en that it does get fast-tracked.

In the fourth quar­ter there’s Am­gen’s Repatha (evolocum­ab) and No­var­tis’ Zyka­dia (cer­i­tinib) — which low­ers cho­les­terol and treats lung can­cer, re­spec­tive­ly. And if things go smooth­ly, Eli Lil­ly will pock­et a good chunk of rev­enue from mar­ket­ing fruquin­tinib, a prod­uct de­vel­oped by Chi­na’s Hutchi­son MediPhar­ma, which lays claim to be­ing the first true home grown drug to aim at a mar­ket­ing launch. It treats col­orec­tal can­cer, the sec­ond-most preva­lent can­cer in Chi­na.

Here’s the full list:

  1. Fron­tier Biotech: al­bu­ver­tide
  2. Bris­tol My­ers-Squibb: nivolum­ab
  3. Jiang­su Hen­grui Med­i­cine: 19K
  4. CT­TQ: an­lo­tinib hy­drochlo­ride
  5. Jiang­su Hen­grui Med­i­cine: py­ro­tinib
  6. Hutchin­son MediPharm/Eli Lil­ly: fruquin­tinib
  7. As­traZeneca: Lyn­parza  (ola­parib)
  8. Ei­sai: Lenvi­ma (lenva­tinib)
  9. Fi­bro­Gen/AZ: rox­adu­s­tat
  10. Han­soh: PEX168
  11. No­var­tis: Zyka­dia (cer­i­tinib)
  12. Am­gen: Repatha (evolocum­ab)
  13. As­cle­tis: danopre­vir
  14. Gilead: Har­voni (ledi­pasvir/so­fos­bu­vir)
  15. Eli Lil­ly: Trulic­i­ty (du­laglu­tide)
  16. Gilead: Vem­lidy (teno­fovir alafe­namide)

 

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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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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Drug­mak­ers cut prices on av­er­age by more than 60% to get on Chi­na's 2022 NDRL list — re­port

China’s National Reimbursement Drug List (NRDL) is a crystal clear example of the country’s bargaining power in the biotech and pharma market, as more firms have reportedly agreed to cut their prices for 67 new medicines to be included in its national medical insurance coverage starting in January.

Being on the list is lucrative. Essentially, if a biotech or pharma company gets on this list, they’re covered by the biggest insurance network in the country. Given China’s vast population, the Chinese government has significant leverage to decide which medicines can make a profit. While domestic drugmakers are quite willing to play that game, cutting prices significantly in exchange for getting on the list, international companies don’t do it as often.

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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Nurses star in J&J's campaign centered on the importance of nurses who are increasingly stressed, burnt out and quitting the profession (via Johnson & Johnson)

Thank­ful for nurs­es: J&J's new cam­paign aims to re­set pan­dem­ic clock back to grat­i­tude

In the early days of the pandemic, people cheered for nurses – delivering food, writing thank you notes and ringing bells nightly to show their appreciation. But something shifted this summer, and now Johnson & Johnson wants to remind people of the gratitude that nurses still deserve.

Call it politics or pandemic weariness or the result of almost two years of a deadly pandemic, but nurses today face threats and mistreatment from patients and their angry family members. And nurses are leaving the profession in record numbers.

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.

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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