FDA calls for re­peat bioe­quiv­a­lence stud­ies af­ter un­cov­er­ing 'in­valid' da­ta from two In­di­an CROs

Last year
Outsourcing
FDA+

As­traZeneca wa­gers on $500M buy­out, plucks PhI­II drug for Alex­ion’s rare dis­ease pipeline — and jumps straight in­to risky field

Last year
Deals

Safe­ty fears force Pfiz­er to change piv­otal DMD gene ther­a­py tri­al pro­to­col

Last year
R&D
Cell/Gene Tx

George Church, his stu­dents, and top VCs go na­tion­wide with a biotech train­ing camp

Last year
Startups

Bio­gen can't es­cape co­pay kick­back law­suits as Hu­mana al­leges 'seed­ing and sweep­ing' scheme

Last year
Pharma

Bio­haven turns out a dud in fa­tal neu­rode­gen­er­a­tive dis­ease, cast­ing doubt on drug's chances in ALS

Last year
R&D

Mer­ck, Pfiz­er end patent feud over pneu­mo­coc­cal vac­cines with roy­al­ty-cen­tered set­tle­ment

Last year
Pharma

DE­VEL­OP­ING News: Ac­celeron ne­go­ti­at­ing $11B buy­out; 11 promis­ing biotech star­tups; Changes ga­lore at No­var­tis; #ES­MO21 high­lights; and more

Last year
Weekly

Days of heat­ed ru­mors cul­mi­nate in a re­port that Ac­celeron is in ad­vanced buy­out talks

Last year
Deals
R&D

New ARIA cas­es dog Bio­gen's Aduhelm launch in an­oth­er po­ten­tial blow to block­buster hopes — an­a­lyst

Last year
FDA+

Mi­cro­cap gene ther­a­py play­er says three chil­dren suf­fered se­ri­ous side ef­fects in PhI/II study

Last year
R&D
Cell/Gene Tx

Lon­za un­veils new ex­pan­sion plans at Swiss man­u­fac­tur­ing sites, cap­ping off a very busy pan­dem­ic

Last year
Manufacturing

Catal­ent inks deal with Phath­om to make GI drug at re­cent­ly-ren­o­vat­ed Ken­tucky site

Last year
Outsourcing
Manufacturing

UNC re­searchers re­port a new way to charge CAR-T against sol­id tu­mors

Last year
Discovery
Cell/Gene Tx

Fol­low­ing con­tro­ver­sial Aduhelm ap­proval, DC-based neu­rol­o­gy cen­ter bans Bio­gen rep­re­sen­ta­tives from its of­fices — re­port

Last year
Pharma
FDA+

Fore­site re­cruits Prin­cip­ia vet Mar­tin Babler — and his old team — to oc­cu­py the C-suite of a start­up

Last year
People
Startups

The FDA ob­jects to biotech bil­lion­aire Bob Dug­gan’s PhI­II plans — and he’s not budg­ing

Last year
FDA+

In­side look: How a po­ten­tial part­ner­ship turned in­to a $1.9B buy­out for Sanofi

Last year
Deals

Lux­tur­na in­ven­tor Jean Ben­nett starts a new gene ther­a­py com­pa­ny to tack­le rare dis­eases left be­hind by phar­ma, VCs

Last year
Startups

Aerie fires CEO af­ter lead pro­gram flop, com­ments about pri­ma­ry end­points be­ing 'not re­quired'

Last year
People
Pharma

When ef­fi­ca­cy is bor­der­line: FDA needs to get more con­sis­tent on close-call drug ap­provals, agency-fund­ed re­search finds

Last year
FDA+

Div­ing deep­er in­to in­her­it­ed reti­nal dis­or­ders, No­var­tis gob­bles up an­oth­er bite-sized op­to­ge­net­ics biotech

Last year
Deals
Cell/Gene Tx

Zol­gens­ma patent spat brews be­tween No­var­tis and Re­genxbio as top No­var­tis gene ther­a­py ex­ec de­parts

Last year
Cell/Gene Tx

Ex-My­lan em­ploy­ee pleads guilty to in­sid­er trad­ing, il­le­gal­ly deal­ing on FDA ap­provals, earn­ings and Up­john merg­er

Last year
Pharma
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