pharmaphorum

In today’s headlines: pharmaphorum.com/news

#news #pharma #lifesciences #pharmanews #pharmaindustry

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.

pharmaphorum.com/news/lilly-u...

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.

pharmaphorum.com/news/can-glp...

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.

pharmaphorum.com/news/hansa-c...

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.

pharmaphorum.com/news/welsh-f...

In today’s headlines: pharmaphorum.com/news

#news #pharma #lifesciences #pharmanews #pharmaindustry

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.

buff.ly/8wVGLmt

#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.

buff.ly/gQC7fjs

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.

pharmaphorum.com/news/cancer-...

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.

buff.ly/GbfCB89

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.

pharmaphorum.com/news/uk-puts...

In today’s headlines: pharmaphorum.com/news

#news #pharma #lifesciences #pharmanews #pharmaindustry

'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.

Ascendis scores FDA approval for weekly dwarfism drug Children with achondroplasia will soon have the option of a once-weekly - rather than daily - injection, courtesy of Ascendis' newly approved Yuviwel.

Denmark's #AscendisPharma is planning to #launch its once-weekly therapy for a form of #dwarfism in the #US in the second quarter, after securing #FDAapproval for the drug.

CMS extends deadline for MFN pricing pilot scheme CMS has extended the deadline for its Medicaid drug pricing pilot, GENEROUS, to "provide interested drug manufacturers more opportunity to join."

The Centers for Medicare & Medicaid Services (#CMS) in the US has extended the deadline for companies to take part in its #GENEROUS pilot programme, designed to implement Most-Favoured Nation (#MFN) #pricing for outpatient drugs reimbursed by #Medicaid.

pharmaphorum.com/news/cms-ext...

#UnitedTherapeutics plans to file for approval of #ralinepag as a treatment for #pulmonaryarterialhypertension (PAH) before the end of the year, after positive results in a phase 3 trial.

pharmaphorum.com/news/uniteds...

In today’s headlines: pharmaphorum.com/news

#news #pharma #lifesciences #pharmanews #pharmaindustry

Novo Nordisk plans €432m investment in Irish GLP-1 plant Novo Nordisk invests €432m in an Irish manufacturing plant as it prepares for regulatory approvals of its Wegovy pill outside the US

#NovoNordisk has said it will invest DKK 3.2 billion (€432 million) in a #manufacturingplant in #Ireland that will be used to produce its "current and future" #GLP1 agonist-based therapies for diseases like #obesity and #type2diabetes.

#Roche's oral BTK inhibitor #fenebrutinib has hit the spot in the final trial in its #phase3 programme, in relapsing #multiplesclerosis (RMS), and is now being prepared for #regulatory filings.

pharmaphorum.com/news/after-p...

#Ipsen's #Ojemda is on course to become the first targeted medicine in the #EU for some #children with a form of #braincancer known as #lowgradeglioma, after it was recommended for approval by the #EMA's human medicines committee. #CHMP

pharmaphorum.com/news/chmp-ba...

New biotech Atrium born out of Novartis/Avidity marriage Atrium Therapeutics has launched with $270m in funding and two preclinical siRNA candidates for rare genetic cardiomyopathies.

As Novartis completed its $12 billion takeover of Avidity, a new #cardiology-focused #biotech was spun out – #AtriumTherapeutics – with two preclinical programmes and #funding of $270 million.

pharmaphorum.com/news/new-bio...

NHS "isn't delivering equitable care for rare diseases" A Genetic Alliance UK report claims the NHS is failing to meet the needs of many of the 3.5 million people in the country who live with rare diseases.

A report from #GeneticAllianceUK has claimed that the #NHS is failing to meet the needs of many of the 3.5 million people in the country who live with a #raredisease.

buff.ly/tibDyEk

In today’s headlines: pharmaphorum.com/news

#news #pharma #lifesciences #pharmanews #pharmaindustry

#Moderna's combined #vaccine for both #influenza and #COVID19, mRNA-1083, has been recommended for approval in the #EU under mCombriax brand name.

buff.ly/0UBHBX6

Boehringer gets FDA's second 'national priority' approval Boehringer Ingelheim's lung cancer drug Hernexeos has become the second medicine approved after an FDA national priority review.

#BoehringerIngelheim has become the second company to get a product approved under the #FDA's #nationalpriorityvoucher programme, claiming the go-ahead for first-line use of #lungcancer drug #Hernexeos.

pharmaphorum.com/news/boehrin...

US lawmakers take FDA to task over rare diseases record Lawmakers and patient advocates in the US are concerned that the FDA's regulation of rare disease therapies has been inconsistent and overly cautious.

At a meeting of the #US #SenateSpecialCommittee on Aging, lawmakers and patient advocates said they were concerned that the #FDA's handling of therapies for #rarediseases has been inconsistent and overly cautious.

pharmaphorum.com/news/us-lawm...

Generate's IPO gets over the line, raising $400m AI-powered drug developer Generate Biomedicine completes a $400m IPO, the largest for biotech on the Nasdaq so far this year.

#GenerateBiomedicines has completed its #IPO, raising an impressive $400 million that makes it the largest listing for a #biotech on the #Nasdaq so far this year.

pharmaphorum.com/news/generat...

Eisai unveils digital platform for kidney cancer patients Eisai has launched a 'digital destination', called Kompass, that aims to support patients after they have been given a diagnosis of kidney cancer.

#Eisai has launched a 'digital destination', called #Kompass, that aims to support #patients after they have been given a #diagnosis of #kidneycancer.