→ Fritz Ger­ber, the 92-year-old ex-Roche CEO who steered the com­pa­ny to a ma­jor­i­ty stake in Genen­tech, has died. Ger­ber was CEO from 1978 to 1998, and chair­man for a few years af­ter that. The com­pa­ny cred­its him with tak­ing a lead­ing role in ac­quir­ing a ma­jor­i­ty stake in Genen­tech, a foun­da­tion­al move that led to the full buy­out 11 years ago. Deals to ac­quire PCR tech­nol­o­gy and the takeover of Boehringer Mannheim al­so set up a big play in di­ag­nos­tics, where Roche is a world leader to­day.

→ Can ADC Ther­a­peu­tics pull off an IPO in the mid­dle of a pan­dem­ic, af­ter try­ing and fail­ing ear­li­er? We’ll find out soon. The Eu­ro­pean biotech has set its range for an IPO at $16 to $18 a share, with plans to sell 7.3 mil­lion shares to in­vestors and up to $1.1 mil­lion shares to un­der­writ­ers. Al­to­geth­er they could reap as much as $151 mil­lion-plus, de­pend­ing on how it all shakes out. There has been a string of suc­cess­ful biotech IPOs since the pan­dem­ic hit hard in the US and Eu­rope, like­ly in­spir­ing a slate of com­pa­nies to brush off old fi­nanc­ing plans. ADC with­drew its IPO last fall, cit­ing “ad­verse mar­ket con­di­tions.”

→ The Re­gen­eron Ge­net­ics Cen­ter has struck a deal to col­lab­o­rate with the Uni­ver­si­ty of Col­orado’s Col­orado Cen­ter for Per­son­al­ized Med­i­cine. In the deal, Re­gen­eron will se­quence 450,000 DNA sam­ples and cor­re­spond­ing health records from de-iden­ti­fied pa­tients. Their work will help in­form trans­la­tion­al re­search projects as well as back bet­ter pre­scrib­ing rou­tines.

→ Is­raeli biotech Pro­tal­ix now has de­tailed late-stage da­ta to back up its pitch to mar­ket its en­zyme-re­place­ment ther­a­py for Fab­ry dis­ease. The BRIDGE study, a sin­gle-arm switch-over study eval­u­at­ing the safe­ty and ef­fi­ca­cy of the com­pa­ny’s pe­gu­ni­gal­si­dase al­fa (or PRX-102) in up to 22 Fab­ry pa­tients pre­vi­ous­ly treat­ed with Take­da’s agal­si­dase al­fa (Re­pla­gal), showed sub­stan­tial im­prove­ment in re­nal func­tion with the Pro­tal­ix drug. In pa­tients who switched from the Take­da ther­a­py to PRX-102 — the mean im­prove­ment was from ‑5.90 mL/min/1.73m2/year while on agal­si­dase al­fa to -1.19 mL/min/1.73m2/year on PRX-102 in all pa­tients.

Da­ta from with two oth­er Phase III stud­ies are still ex­pect­ed, but Pro­tal­ix and part­ner Chiesi are plan­ning to sub­mit an ap­pli­ca­tion to mar­ket PRX-102 un­der the ac­cel­er­at­ed ap­proval path­way, de­spite Covid-19 and oth­er in­ter­rup­tions.

→ New­port Beach, CA-based cell ther­a­py play­er jCyte has li­censed the ex-US rights for its lead pro­gram to Japan’s San­ten for $50 mil­lion up­front. Dubbed Jcell, the prod­uct con­sists of al­lo­gene­ic hu­man reti­nal prog­en­i­tor cells to treat re­tini­tis pig­men­tosa, where gene mu­ta­tions lead to pro­gres­sive de­gen­er­a­tion of the reti­na. The US biotech can tap in­to a $12 mil­lion con­vert­ible debt and $190 mil­lion in mile­stones.

On the third straight Monday that the world wakes up to positive vaccine news, AstraZeneca and Oxford are declaring a new Phase III milestone in the fight against the pandemic.

With an average efficacy of 70%, the headline number may appear less impressive than the 95% and 94.5% protection that Pfizer/BioNTech and Moderna have boasted in the past two weeks, respectively. But the British partners have several other bright spots going for their candidate. One of the two dosing regimens tested in Phase III showed a better profile, bringing efficacy up to 90%; the adenovirus vector-based vaccine requires minimal refrigeration, which may mean easier distribution; and AstraZeneca has pledged to sell it at a fraction of the price that the other two vaccine developers are charging.

As a large multinational corporation, Eli Lilly has their hands in boundless projects, from cancer and immuno-oncology to diabetes, psoriasis and Crohn’s disease. But Friday they signaled a shift in their R&D focus toward genome editing, leaping into a cutting-edge field CEO Dave Ricks had shied away from as recently as January 2019.

The big pharma is ponying up $100 million upfront to partner with Precision BioSciences, focusing initially on Duchenne muscular dystrophy and two other undisclosed in vivo targets. Lilly is also acquiring $35 million worth of the biotech’s stock, and has the option to develop three additional in vivo therapies.

Pfizer and BioNTech’s request for emergency authorization of its Covid-19 vaccine is now in the FDA’s hands. Regulators caught the application Friday afternoon in an open field dash to the goal line.

The agency immediately marked Dec 10 on the calendar for an advisory committee meeting to discuss the request. Pfizer and BioNTech first announced the submission was coming on Friday morning, and Pfizer CEO Albert Bourla confirmed the filing in a video statement later that afternoon. The “historic day,” as Bourla called it, came just 248 days after the pharma first announced plans to develop the candidate with BioNTech — a process which typically takes years.

The transatlantic biotech ADC Therapeutics is getting a speedy review for its anti-body drug conjugate loncastuximab tesirine (Lonca), developed for relapsed or refractory diffuse large B-cell lymphoma.

ADC $ADCT said Friday morning that the FDA put their drug on the fast lane, providing a priority review for the drug with a May 21 PDUFA date. The biotech won over regulators with Phase II data that reflected an overall response rate of 48.3% (70/145 patients) and a complete response rate of 24.1%.