We’re con­tin­u­ing to see big in­vest­ments in the glob­al bio­phar­ma man­u­fac­tur­ing in­fra­struc­ture.

Wednes­day morn­ing Catal­ent put out the word that it is in­vest­ing $130 mil­lion in its late-stage ops at its gene ther­a­py fa­cil­i­ty in Har­mans, MD. The con­tract man­u­fac­tur­er has been sink­ing a sig­nif­i­cant amount of mon­ey in­to gene ther­a­py as that field con­tin­ues to boom.

Mer­ck KGaA pre­ced­ed that an­nounce­ment with the news that the Ger­man bio­phar­ma play­er is trig­ger­ing a €59 mil­lion ex­pan­sion of its HPA­PI and ADC man­u­fac­tur­ing ca­pa­bil­i­ties and ca­pac­i­ty at its fa­cil­i­ty near Madi­son, WI. That move will add 50 new jobs as they ramp up work on the on­col­o­gy pipeline with new tech that al­lows con­tin­u­ous man­u­fac­tur­ing of AD­Cs.

“AD­Cs have post­ed in­cred­i­ble growth over the last decade, and reg­u­la­to­ry agen­cies’ ap­provals in re­cent years demon­strate their promise as a tar­get­ed ther­a­py,” said An­drew Bulpin, head of process so­lu­tions at the com­pa­ny’s life sci­ence busi­ness sec­tor.

Jazz hands over $10M to launch a new can­cer dis­cov­ery pact, with $210M up for grabs

Redx is pick­ing up $10 mil­lion in cash af­ter ink­ing a new dis­cov­ery and de­vel­op­ment pact with Jazz Phar­ma­ceu­ti­cals.

The UK biotech will be re­spon­si­ble for ex­plor­ing two can­cer tar­gets on the Ras/Raf/MAP ki­nase (MAPK) path­way. And there’s an­oth­er $10 mil­lion up for grabs if Jazz wants to push ahead in­to year 2, with $200 mil­lion in mile­stones at stake.

This new al­liance comes just a month af­ter As­traZeneca pro­vid­ed a $17 mil­lion life­line to Redx, which has been in and out of hot wa­ter over the years. Right now, things are look­ing up.

J&J signs up for a 2-way col­lab­o­ra­tion with Vivek Ra­maswamy’s Data­vant

Vivek Ra­maswamy’s Data­vant and J&J have linked up on some da­ta shar­ing ini­tia­tives.

Travis May

In this new pact, the phar­ma gi­ant is pick­ing up rights to use Data­vant’s tech to “in­te­grate dis­parate da­ta sets to cre­ate rich, lon­gi­tu­di­nal re­al-world and clin­i­cal datasets to bet­ter un­der­stand the holis­tic pa­tient jour­ney, there­by en­hanc­ing the de­sign and ex­e­cu­tion of Janssen’s clin­i­cal de­vel­op­ment pro­grams for pa­tients.”

In re­turn, J&J is of­fer­ing feed­back to Data­vant on the prod­ucts and ser­vices it’s pro­vid­ing the in­dus­try.

Travis May, Data­vant CEO, not­ed: “The abil­i­ty to safe­ly con­nect da­ta from across the health­care ecosys­tem to un­der­stand the safe­ty and ef­fi­ca­cy of, and ac­cess to drugs cre­ates the op­por­tu­ni­ty to great­ly im­prove pa­tient out­comes, and we look for­ward to build­ing our col­lab­o­ra­tion.”

The FDA on Tuesday released a warning letter sent earlier this month to the Mason, OH-based site of Procter & Gamble Manufactura, raising questions about the list of ingredients on the label and in the electronic filing.

The warning says that for P&G’s over-the-counter Vicks Nyquil Severe Hot Remedy Cold and Flu Plus Congestion, there’s a “mismatched” list of active ingredients between the labeling and the electronic listing file. The listing file for the active ingredients did not match the active ingredients in the electronic file.

The Federal Trade Commission has gotten involved in a patent feud over Supernus’ Parkinson’s drug Apokyn, a case the agency said may have ‘‘significant implications” for patients who rely on the drug.

Sage Chemical won the first generic approval for its Apokyn formulation (also known as apomorphine hydrochloride injection) back in 2022. The non-ergoline dopamine agonist is approved to treat Parkinson’s symptoms during “off episodes,” such as difficulty moving, tremors and intense cramping. However, regulators specified that the approval pertained to the generic drug cartridges only, not the injector pen required for administration.