Chi­na-based bio­phar­ma I-Mab has land­ed a part­ner­ship with Shang­hai’s Hangzhou Qiantang New Area to man­u­fac­ture drugs lo­cal­ly and speed up the com­pa­ny’s path to­ward com­mer­cial­iza­tion.

The deal will help it com­mer­cial­ize felzartam­ab, a mon­o­clon­al an­ti­body that tar­gets mul­ti­ple myelo­ma, in Chi­na. Hangzhou has start­ed op­er­at­ing on what it calls a Phase I site and start­ed con­struc­tion in De­cem­ber on an 80,000 square-me­ter spot for Phase II.

“To­day’s an­nounce­ment demon­strates the Com­pa­ny’s com­mit­ment to trans­lat­ing our sci­en­tif­ic in­no­va­tion in­to clin­i­cal and com­mer­cial val­ue as soon as pos­si­ble so that we can pro­vide more high-qual­i­ty, af­ford­able op­tions for pa­tients through lo­cal­ly-man­u­fac­tured, in­no­v­a­tive drugs,” CCO Yifei Zhu said. “This brings us one step clos­er to our new com­mer­cial mod­el that in­te­grates man­u­fac­tur­ing, dis­tri­b­u­tion and sales.”

Mul­ti­ple myelo­ma is the sec­ond most com­mon hema­to­log­ic ma­lig­nan­cy in Chi­na, mak­ing up 1% of all can­cers and 13% of all blood ma­lig­nan­cies.

Co-founder Jing­wu Zang be­came the act­ing CEO at the start of the year when Joan Shen stepped down to pur­sue oth­er in­ter­ests at the close of 2021. The com­pa­ny made head­lines in 2020 with a $2.9 bil­lion li­cens­ing deal with Ab­b­Vie for its CD47 drug, and in Sep­tem­ber, there were re­ports the com­pa­ny was con­sid­er­ing sell­ing a stake of it­self.

Gran­ules is­sued ‘mi­nor ob­ser­va­tions’ af­ter in­spec­tion

An In­di­an phar­ma was is­sued three ob­ser­va­tions by the FDA, fol­low­ing a pre-ap­proval in­spec­tion at the end of last month, the com­pa­ny said.

Gran­ules Phar­ma­ceu­ti­cals, in Chan­til­ly, Vir­ginia, was in­spect­ed from Jan. 24-28.

“We are glad to have com­plet­ed yet an­oth­er au­dit with mi­nor ob­ser­va­tions that we will re­spond to with­in the stip­u­lat­ed time pe­ri­od,” di­rec­tor Priyan­ka Chig­u­ru­pati said in a state­ment.

The com­pa­ny had an ab­bre­vi­at­ed new drug ap­pli­ca­tion. Ap­proved by the FDA at the end of Jan­u­ary for its potas­si­um chlo­ride bioe­quiv­a­lent treat­ment of low potas­si­um lev­els. It al­so re­ceived ap­proval for its AN­DA  for Bupro­pi­on Hy­drochlo­ride ex­tend­ed-re­lease tablets to treat de­pres­sion and sea­son­al af­fec­tive dis­or­der. That marked the 50th AN­DA ap­proval from the FDA.

The notorious drug testing company Valisure, which has made a name for itself by forcing FDA’s hand with some of its safety-related uncoverings, received a letter this week after the FDA uncovered violations at its Connecticut-based testing lab in 2021.

The letter, which was sent on Dec. 5, stated that the FDA is “concerned” that Valisure was not aware of  drug supply chain security requirements.

The FDA’s Cardiovascular and Renal Drugs Advisory Committee will meet next Tuesday to discuss whether Cytokinetics’ potential heart drug can safely reduce the risk of cardiovascular death and heart failure in patients with symptomatic chronic heart failure with reduced ejection fraction.

The drug, known as omecamtiv mecarbil and in development for more than 15 years, has seen mixed results, with a first Phase III readout from November 2020 hitting the primary endpoint of reducing the odds of hospitalization or other urgent care for heart failure by 8%. But it also missed a key secondary endpoint analysts had pegged as key to breaking into the market.

The generics manufacturer Lupin has been given another Form 483 from the FDA this year.

US regulators inspected Lupin’s pharmaceutical manufacturing site in the town of Mandideep, India from Nov. 14 through Nov. 23, with the 14-page report marking 16 observations.

The inspection report stated that the site did not have the appropriate controls over its computer systems to ensure that changes in “master production” or records are only done by authorized personnel, along with written procedures not being established to conduct annual reviews of records associated with drug batches.

Add AbbVie to the list of pharma companies currently facing age discrimination allegations.

Pennsylvania resident Thomas Hesch filed suit against AbbVie on Wednesday, accusing the company of passing him over for promotions in favor of younger candidates.

Despite 30 years of pharma experience, “Hesch has consistently seen younger, less qualified employees promoted over him,” the complaint states.