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The #FDA has issued updated #guidance that aims to make it easier for drugmakers to bring #biosimilars of patent-expired #biologicdrugs to market, in the hope of reducing medicine #prices.

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Months of legal wrangling between #NovoNordisk and telehealth company #HimsandHers has been set aside, as the two companies agree to work together once again on the sale of #GLP1agonists for #weightloss.

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Incyte breaks new ground in anal cancer with EU approval Incyte claims EU approval for Zynyz as the first systemic therapy for anal cancer, as J&J gets the nod for wider use of Akeega in prostate cancer.

A regimen based on #Incyte's #PD1inhibitor Zynyz and chemotherapy has become the first systemic treatment to be approved in the #EU for advanced squamous cell carcinoma of the anal canal (#SCAC).

#GSK has signed an eleventh-hour agreement to give #Alfasigma rights to its #primarybiliarycholangitis (PBC) therapy linerixibat, which is under #regulatoryreview in most major pharma markets #worldwide.

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#Roche's recent run of positive study results with giredestrant has come to an end with the #failure of the #persevERAtrial in HR-positive, HER2-negative advanced #breastcancer.

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Safety concerns prompt Ipsen to pull Tazverik from market Ipsen is voluntarily withdrawing its EZH2 inhibitor Tazverik from sale after a clinical trial suggested a link with secondary blood cancers.

#Ipsen is voluntarily withdrawing its EZH2 inhibitor #Tazverik from sale after a clinical trial suggested a link with #secondarybloodcancers.

CBER chief Vinay Prasad to leave FDA once again For the second time in less than a year, Vinay Prasad has departed from the FDA, after a string of controversial regulatory decisions.

For the second time in less than a year, #VinayPrasad has departed from the #FDA, after #controversial decisions relating to the review of #vaccines and #raredisease therapies.

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Servier snaps up cancer biotech Day One in $2.5bn deal Servier has made a takeover offer for Day One and its fast-growing glioma therapy Ojemda, as it pitches to drive sales above €10bn by 2030.

Rumours earlier this week of an imminent #takeover offer for #DayOneBiopharmaceuticals proved well-founded, but missed the mark on the identity of the acquirer.

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Zealand hit as Roche-partnered obesity drug disappoints Shares in Zealand lost a third of their value today, after the biotech reported phase 2 data with Roche-partnered weight-loss therapy petrelintide.

#Shares in #ZealandPharma lost around a third of their value today, after it reported phase 2 data with #Roche-partnered #weightloss therapy #petrelintide.

Daiichi teams up with GAIA for cholesterol DTx in Europe Daiichi Sankyo has licensed European rights to GAIA's digital therapeutic for people with high cholesterol, currently in phase 3 testing.

#DaiichiSankyo's European division has signed a partnership with German #digitalhealth company #GAIA to sell a #digitaltherapeutic (DTx) designed to support people with high #cholesterol levels.

#Pfizer has claimed its first #regulatoryapproval for a #GLP1 agonist in #obesity, getting a green light in #China for ecnoglutide, a once-weekly #injectable drug licensed from Hangzhou-based #SciwindBiosciences in February.

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#JohnsonandJohnson's #Tecvayli has been approved as part of a #combinationregimen with its #Genmab-partnered #DarzalexFaspro as a second-line therapy for relapsed or refractory #multiplemyeloma, just 55 days after it was filed with the FDA.

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Alnylam bets on Tenaya RNAi tech, and other licensing news This week's round-up of pharma licensing deals features alliances involving Tenaya Therapeutics, Sino Bio, Antengene, and A2A Pharma.

This week's round-up of #pharmalicensingdeals features alliances involving #TenayaTherapeutics, #SinoBio, #Antengene, and #A2APharma.

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Lilly unveils employer scheme for weight-loss drug Zepbound Eli Lilly has added another channel to its selling options for obesity therapy Zepbound in the US, launching a programme directed at employers.

#EliLilly has added another channel to its selling options for obesity therapy #Zepbound in the #US, launching a programme directed at #employers.

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PepGen slumps as FDA places hold on lead drug Shares in PepGen fell sharply after the FDA placed a partial clinical hold on its lead drug for rare neuromuscular disease DM1.

#Shares in #PepGen were down more than 21% after the #FDA placed a #partialclinicalhold on its lead drug PGN-EDODM1, for rare genetic muscle disorder #myotonicdystrophytype1 (DM1).

Can GLP-1 drugs help tackle addiction? New research has lent weight to the intriguing idea that GLP-1 agonists may help people with substance use disorders break their addiction.

New research has lent weight to the intriguing idea that #GLP1 agonists may have a role to play in helping people with #substanceusedisorders (SUD) break their #addiction.

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Hansa closes on FDA verdict for transplant drug imlifidase The FDA has started reviewing Hansa's imlifidase for highly sensitised adults needing a kidney transplant, but not in the requested rapid timeframe.

The #FDA has started a review of #HansaBiopharma's #imlifidase for patients who need a #kidneytransplant, but for whom finding a donor is particularly challenging, with a decision due before the end of the year.

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Welsh firm Antiverse raises funds for AI antibody platform Cardiff's Antiverse has raised $9.3m to develop its AI-based design platform for antibodies against hard-to-reach targets like GPCRs and ion channels.

#UKbiotech #Antiverse has raised $9.3 million to accelerate its #drugdiscovery programmes, based on an #AI-powered platform for designing #antibodybasedtherapeutics.

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Five #scientificteams from around the world will receive up to £20 million each in a new round of #funding under the UK and US #CancerGrandChallenges initiative.

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#Moderna has agreed to settle #litigation with #ArbutusBiopharma and Roivant's #Genevant that claimed its blockbuster #COVID19vaccine infringed #patents, with an upfront payment of $950 million.

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Cancer risk scuppers Kyowa Kirin's autoimmune disease drug Kyowa Kirin has terminated all clinical trials of its anti-OX40L antibody rocatinlimab, after cases of cancer were seen in patients taking the drug.

#KyowaKirin has terminated all clinical trials of its anti-OX40L antibody #rocatinlimab, after cases of #cancer were seen in patients taking the drug.

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In a move that will delight #NovoNordisk and #EliLilly, the #FDA has sent #warningletters to 30 #telehealth companies, accusing them of #illegallymarketing #compounded #GLP1 agonist formulations.

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UK puts £50m behind expanded clinical trials drive The UK has awarded nearly £50m in funding for equipment to help the NHS carry out commercial clinical trials, with a focus on primary care capacity.

The #UKgovernment is providing nearly £50 million in funding for #equipment that it says will help the #NHS carry out commercial #researchprojects and #clinicaltrials, funded in part by the pharma industry.

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'Dismal' survival demands change in bile duct cancer therapy International cancer experts have called for big changes to bile duct cancer, which kills three-quarters of patients within a year of diagnosis.

An international group of #cancerexperts has called for fundamental change to healthcare approaches for #bileductcancer, which kills three-quarters of #patients within a year of #diagnosis.

Quell takes new Treg into clinic after transplant study halt Quell Therapeutics changes tack, starting trials of a CAR-Treg in rheumatoid arthritis and systemic sclerosis and sidelining its transplant therapy.

UK biotech #QuellTherapeutics has started #humantrials of #autologousCARTreg therapy QEL-005 in #rheumatoidarthritis and #systemicsclerosis, after pressing pause on its former lead programme for organ transplant rejection.