Hovione executives Jean-Luc Herbeaux and Guy Villax stand in front of their booth at CPhI in Milan (Hovione PR)

Hov­ione plots glob­al ex­pan­sion project, look­ing to boost ca­pac­i­ty on both sides of the At­lantic

Hov­ione is go­ing glob­al with its man­u­fac­tur­ing ex­pan­sion, from New Jer­sey all the way to Por­tu­gal.

The CD­MO an­nounced last week it would put $170 mil­lion in­to ex­pan­sions in Por­tu­gal, Ire­land and NJ, in an ef­fort to in­crease its glob­al ca­pac­i­ty by 25%. The move fol­lows an on­go­ing ef­fort since 2016 to ex­pand.

In a press re­lease, COO Jean-Luc Her­beaux said:

These in­vest­ments re­in­force our in­te­grat­ed spe­cial­ized of­fer glob­al­ly, pro­vid­ing our clients with a line of sight for their projects. Fo­cus is placed on fa­cil­i­tat­ing and speed­ing up the drug de­vel­op­ment cy­cle and launch, by pro­vid­ing API man­u­fac­tur­ing, Par­ti­cle En­gi­neer­ing and Tablet­ing ser­vices in each site. Our strat­e­gy con­tin­ues to be to grow or­gan­i­cal­ly via in­vest­ments in our ex­ist­ing sites, which are de­signed for pur­pose. This re­duces the com­plex­i­ty as­so­ci­at­ed with the growth jour­ney and al­lows us to fo­cus our man­age­ment at­ten­tion on what counts most, i.e. guar­an­tee­ing that our clients go to mar­ket with qual­i­ty, safe and ef­fec­tive med­i­cines for their pa­tients.

In New Jer­sey, Hov­ione will add a 31,215-square-foot build­ing next to an al­ready-ex­ist­ing fa­cil­i­ty in East Wind­sor. The move will bring com­mer­cial spray-dry­ing ca­pac­i­ty on­line by 2023, and fur­ther in­vest­ments will help the com­pa­ny fac­tor US-based man­u­fac­tur­ing up through com­mer­cial stage.

In Ire­land, an al­ready-ex­ist­ing site in Cork will be up­grad­ed to add high­ly-po­tent API pro­duc­tion. That ex­pan­sion is set to add an­oth­er 100 jobs over the next three years as Hov­ione plans to add on to the al­ready-ex­ist­ing work­force of around 200. The site has been in op­er­a­tion since 2009.

And in Por­tu­gal, Hov­ione will in­crease its chem­i­cal syn­the­sis ca­pac­i­ty for HPA­PIs. The build­ing will get a new com­mer­cial spray dry­er, which takes a liq­uid stream and sep­a­rates the solute as a sol­id and the sol­vent in­to a va­por. This en­ables the process to be ful­ly au­to­mat­ed and con­tin­u­ous.

“Hov­ione is in it for life and what bet­ter way to man­i­fest this than through ex­pan­sion of our glob­al ca­pac­i­ty and ca­pa­bil­i­ties. Our sus­tain­able or­gan­ic growth strat­e­gy will al­low us to keep true to those val­ues that have been guid­ing us for more than 60 years,” CEO Guy Vil­lax said in a press re­lease.

The CD­MO has 60 years of ex­pe­ri­ence un­der its belt. There are four ex­ist­ing man­u­fac­tur­ing sites in the US, Chi­na, Ire­land and Por­tu­gal, and R&D labs in Lis­bon, Por­tu­gal and New Jer­sey.

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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One work­er at a Lat­vian man­u­fac­tur­er is dead af­ter a fire breaks out at fa­cil­i­ty

A press release referred to it as simply, “the incident.” But a fire at an Olainfarm site in Latvia last week has left one person dead, and injured another, the company announced Monday.

Just before midnight Nov. 26, a fire broke out in the production building of JSC Olainfarm,  as the result of an “accident,” a company spokesperson said in an email to Endpoints News. The two victims were both company employees, and the causes of the accident are still being determined.

Fu­ji­film Diosynth dumps an­oth­er $454M in­to its sup­ply chain, this time at a fa­cil­i­ty in the UK

Fujifilm Diosynth Biotechnologies is in the middle of a monumental point in the company’s 10-year history, and the CDMO is about to grow even more, as it sets out to be the “beating heart” of the UK’s North East Life Sciences ecosystem.

A site in Billingham, Teeside, UK will receive a $453.72 million investment package from the manufacturer to double the existing footprint and create the largest multi-modal biopharmaceutical manufacturing site in the UK, bringing another 350 jobs to the region by late 2023.

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In­cor­po­rat­ing Ex­ter­nal Da­ta in­to Clin­i­cal Tri­als: Com­par­ing Dig­i­tal Twins to Ex­ter­nal Con­trol Arms

Most drug development professionals are familiar with the nerve-racking wait for the read-out of a large trial. If it’s negative, is the investigational therapy ineffective? Or could the failure result from an unforeseen flaw in the design or execution of the protocol, rather than a lack of efficacy? The team could spend weeks analyzing data, but a definitive answer may be elusive due to insufficient power for such analyses in the already completed trial. These problems are only made worse if the trial had lower enrollment, or higher dropout than expected due to an unanticipated event like COVID-19. And if a trial is negative, the next one is likely to be larger and more costly — if it happens at all.

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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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.