Katherine Lewin

Merck reported mixed results from KEYLYNK-001 Phase 3 trial testing Keytruda plus chemotherapy and Lynparza in ovarian cancer patients. While progression-free survival improved, overall survival goals weren't met. The study involved Merck and AstraZeneca's collaboration on treatments for BRCA non-mutated advanced epithelial ovarian cancer.

ICER's draft report indicates Vertex's non-opioid pain drug suzetrigine could be cost-effective at $420 per week compared to hydrocodone bitartrate and acetaminophen, mainly due to avoided opioid use disorder costs. The drug awaits FDA approval with a PDUFA date of January 30, 2025.

Atea Pharmaceuticals reported positive Phase 2 trial results for its hepatitis C combination therapy of bemnifosbuvir and ruzasvir. The company plans to advance to Phase 3 with a simplified dosing regimen.

Biocon Biologics scored an FDA approval for its Stelara biosimilar, marketed as Yesintek, the company announced Monday.

Olema Oncology and Novartis partner for Phase 3 trial combining palazestrant with Kisqali for breast cancer treatment. Olema secures $250 million private placement from investors including Adage Capital Partners and Bain Capital Life Sciences. CEO Sean Bohen confirms funding for three clinical trials.

Axsome Therapeutics’ narcolepsy drug AXS-12 hit the primary endpoint in its Phase 3 ENCORE trial, showing a statistically significant improvement in the frequency of cataplexy attacks in narcoleptic patients compared with placebo.

Assertio Holdings responded to activist investor Alexander Parker after Parker's firm accused Assertio of fraud. The Buxton Helmsley Group on Friday released an open letter to Assertio’s stockholders, accusing the ...

CinFina Pharma, a subsidiary of the hub-and-spoke biotech CinRx, shared early-stage data for two of its Janssen-licensed obesity candidates at this year’s ObesityWeek. CIN-110, a PYY analog, and CIN-109, a ...

Generic drug manufacturers Heritage Pharmaceuticals and Apotex have agreed to pay $49.1 million to settle allegations from nearly all US states that the companies inflated and manipulated drug prices and ...

Generics giant Teva Pharmaceuticals has been hit with another fine related to its blockbuster multiple sclerosis drug Copaxone, this time by the European Commission. Teva will ...

Eledon Pharmaceuticals’ experimental immunosuppressant helped two patients with type 1 diabetes go insulin-free following an islet cell transplant, the company announced Tuesday. The company's stock {$ELDN} rose about 12% on ...

Lyell Immunopharma is discontinuing several programs and acquiring CAR-T biotech ImmPACT Bio and its suite of clinical-stage candidates for $30 million in upfront cash and 37 ...

A group of four Republicans on the House Committee on Energy and Commerce called for more transparency of clinical trial data funded by taxpayers after a New York Times story ...

No­vo Nordisk is in­vest­ing more than DKK 42 bil­lion ($6 bil­lion) to ex­pand its ex­ist­ing man­u­fac­tur­ing fa­cil­i­ties in Den­mark, most­ly to in­crease its ac­tive phar­ma­ceu­ti­cal in­gre­di­ents (API) ca­pac­i­ty, the com­pa­ny an­nounced Fri­day. The fa­cil­i­ties in Kalund­borg, Den­mark, will be able to man­u­fac­ture mul­ti­ple prod­ucts, in­clud­ing GLP-1s, to “meet fu­ture mar­ket de­mands” as the de­mand for its weight loss prod­uct, We­govy, con­tin­ues to soar. This in­vest­…

Aq­tu­al emerged from stealth on Tues­day with $16 mil­lion in Se­ries A funds and plans to use its cell-free DNA plat­form to de­vel­op a blood test for pa­tients with rheuma­toid arthri­tis in the hopes of more quick­ly get­ting to the best treat­ment. Ac­cord­ing to the Cal­i­for­nia-based pre­ci­sion med­i­cine com­pa­ny, there are more than 20 avail­able drugs in six drug class­es for rheuma­toid arthri­tis — and most pa­tients try two or three drugs be­fore find­ing one that works best.

Idor­sia re­vealed a ma­jor cost re­duc­tion ini­tia­tive on Tues­day, lay­ing off up to 300 peo­ple and re­view­ing its pipeline for pro­grams to cut or out-li­cense. The re­struc­tur­ing fol­lows a warn­ing in Ju­ly, when the com­pa­ny said it was look­ing to re­duce its cash burn by half as it works to build its in­som­nia drug sales. The com­pa­ny said 475 jobs at its head­quar­ters in Switzer­land had been “made re­dun­dant” by can­cel­ing open jobs, not re­plac­ing peo­ple who left and lay…

Verve Ther­a­peu­tics is plan­ning to be­gin an in-hu­man base edit­ing tri­al in the US in pa­tients with het­erozy­gous fa­mil­ial hy­per­c­ho­les­terolemia (HeFH) af­ter the FDA lift­ed a clin­i­cal hold on the com­pa­ny’s IND ap­pli­ca­tion. Verve an­nounced Mon­day that it can now ex­pand its Phase Ib clin­i­cal tri­al in­to the US. The reg­u­la­tor had placed a hold on the IND for VERVE-101 in No­vem­ber of last year, with asks for ad­di­tion­al pre­clin­i­cal and clin­i­cal da­ta.

An ini­tia­tive three years in the mak­ing that aims to cre­ate the largest African an­ces­try ge­nomics re­search data­base has fi­nal­ly launched with some of the biggest phar­ma names in the busi­ness be­hind it. Mehar­ry Med­ical Col­lege, a his­tor­i­cal­ly Black med­ical school in Nashville, along with the Re­gen­eron Ge­net­ics Cen­ter, As­traZeneca, No­vo Nordisk, and Roche, de­vel­oped To­geth­er for CHANGE. The ini­tia­tive has a two-pronged ap­proach: build a ge­nomics data­base with…

Near­ly a year af­ter rais­ing its largest fi­nanc­ing so far, the Dan­ish biotech Min­er­vaX is back with an up­sized fi­nanc­ing round of €54 mil­lion ($57.3 mil­lion) to fund late-stage work for its vac­cine against group B Strep­to­coc­cus, the com­pa­ny an­nounced Wednes­day. Group B Strep­to­coc­cus is a bac­te­ria re­spon­si­ble for near­ly 50% of all life-threat­en­ing in­fec­tions in new­borns. It can al­so lead to oth­er prob­lems in preg­nan­cy, like still­births, ac­cord­ing to Min­e…

The FDA has im­posed a par­tial clin­i­cal hold on In­nate Phar­ma’s IND for its can­cer drug la­cu­tam­ab, lead­ing to a pause on en­roll­ment in two ear­ly-stage tri­als af­ter an “un­ex­pect­ed se­vere ad­verse re­ac­tion” that led to a pa­tient death, the com­pa­ny said Thurs­day. A Phase II and a Phase Ib in­ves­ti­gat­ing the drug were halt­ed af­ter a pa­tient died from he­mo­phago­cyt­ic lym­pho­his­ti­o­cy­to­sis, a rare hema­to­log­ic dis­or­der where cer­tain white blood cells build u…