As gene ther­a­py ri­vals ad­vance, Bio­gen moves clos­er to spin­ning out he­mo­phil­ia drugs, R&D

Lest any­one for­get, Bio­gen is fo­cused pri­mar­i­ly on neu­ro­science. And it’s mov­ing at a steady clip to spin off its he­mo­phil­ia busi­ness in a tac­tic de­signed to un­der­score that strat­e­gy. Bio­gen to­day says the busi­ness will launch as Biover­a­tiv in ear­ly 2017 and trade as $BIVV.

The busi­ness at Biover­a­tiv will start by fo­cus­ing on con­tin­u­ing to com­mer­cial­ize Eloc­tate and Al­pro­lix, which were de­vel­oped in part­ner­ship with Stock­holm-based So­bi. And there’s a pipeline of new projects look­ing at ex­pand­ing their use while adding new ef­forts on gene ther­a­pies and more for he­mo­phil­ia A and B.

An­a­lysts, though, may well be won­der­ing what kind of a fu­ture awaits Biover­a­tiv. Bio­Marin re­cent­ly pro­duced some jaw-drop­ping re­sults for a po­ten­tial­ly once-and-done gene ther­a­py for he­mo­phil­ia A. And there are a va­ri­ety of oth­er ef­forts un­der­way that are al­so look­ing to cure he­mo­phil­ia.

Bio­gen, mean­while, has been con­cen­trat­ing heav­i­ly on its mul­ti­ple scle­ro­sis port­fo­lio, where it makes the bulk of its mon­ey, and a high risk, high re­ward ef­fort in the clin­ic for Alzheimer’s. The com­pa­ny has been un­der in­tense pres­sure for a year now to strike some ma­jor de­vel­op­ment deals as its rev­enue fore­casts have erod­ed as Tec­fidera’s for­tunes start to slide. And it may be hard for the com­pa­ny’s deal­mak­ers to find more promis­ing neu­ro­science work in late-stage de­vel­op­ment.

John Cox

John Cox, a Bio­gen vet who will take the helm at Biover­a­tiv, plans to be among the lead­ers. Cox had this to say in a state­ment:

As an in­de­pen­dent and fo­cused com­pa­ny, we be­lieve that Biover­a­tiv will be unique­ly po­si­tioned to dri­ve progress and ad­vance the stan­dard of care for peo­ple liv­ing with he­mo­phil­ia. Work­ing close­ly with the he­mo­phil­ia com­mu­ni­ty, we hope to trans­form lives by ac­cel­er­at­ing in­no­va­tion for peo­ple and care­givers liv­ing with he­mo­phil­ia.

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In­no­v­a­tive MedTech De­mands Spe­cial­ist Clin­i­cal Tri­al Reg­u­la­to­ry Af­fairs and De­sign

Avance Clinical is the Australian CRO for international biotechs providing world-class clinical research services with FDA-accepted data across all phases. With Avance Clinical, biotech companies can leverage Australia’s supportive clinical trials environment which includes no IND requirement plus a 43.5% Government incentive rebate on clinical spend. The CRO has been delivering clinical drug development services for international biotechs for FDA and EMA regulatory approval for the past 24 years. The company has been recognized for the past two consecutive years with the prestigious Frost & Sullivan CRO Best Practices Award and a finalist in Informa Pharma’s Best CRO award for 2022.

Gold for adults, sil­ver for in­fants: Pfiz­er's Pre­vnar 2.0 head­ed to FDA months af­ter Mer­ck­'s green light

Pfizer was first to the finish line for the next-gen pneumococcal vaccine in adults, but Merck beat its rival with a jab for children in June.

Now, two months after Merck’s 15-valent Vaxneuvance won the FDA stamp of approval for kids, Pfizer is out with some late-stage data on its 20-valent shot for infants.

Known as Prevnar 20 for adults, Pfizer’s 20vPnC will head to the FDA by the end of this year for an approval request in infants, the Big Pharma said Friday morning. Discussions with the FDA will occur first and more late-stage pediatric trials are expected to read out soon, informing the regulatory pathway in other countries and regions.

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FDA ap­proves sec­ond in­di­ca­tion for As­traZeneca and Dai­ichi's En­her­tu in less than a week

AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate Enhertu scored its second approval in less than a week, this time for a subset of lung cancer patients.

Enhertu received accelerated approval on Thursday to treat adults with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, and who have already received a prior systemic therapy.

J&J to re­move talc prod­ucts from shelves world­wide, re­plac­ing with corn­starch-based port­fo­lio

After controversially spinning out its talc liabilities and filing for bankruptcy in an attempt to settle 38,000 lawsuits, Johnson & Johnson is now changing up the formula for its baby powder products.

J&J is beginning the transition to an all cornstarch-based baby powder portfolio, the pharma giant announced on Thursday — just months after a federal judge ruled in favor of its “Texas two-step” bankruptcy to settle allegations that its talc products contained asbestos and caused cancer. An appeals court has since agreed to revisit that case.

CSL is gathering its four business units under a unified brand identity strategy (Credit: CSL company site)

CSL brings Se­qirus, Vi­for un­der par­ent um­brel­la brand in iden­ti­ty re­vamp

CSL is gathering its brands under the family name umbrella, renaming its vaccine and newly acquired nephrology specialty businesses with the parent initials.

CSL Seqirus and CSL Vifor join CSL Plasma and CSL Behring as the four now uniformly branded business units of the global biopharma. The Seqirus vaccine division was formed in 2015 with the combination of bioCSL and its purchase of Novartis’ flu vaccine business. CSL picked up Vifor Pharma late last year in an $11.7 billion deal for the nephrology, iron deficiency and cardio-renal drug developer.

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Seagen interim CEO Roger Dansey and Daiichi Sankyo CEO Sunao Manabe

Paving the way for Mer­ck­'s buy­out, Seagen los­es ar­bi­tra­tion dis­pute with Dai­ichi over ADC tech

As Merck closes in on a potential $40 billion buyout of Seagen, Seagen revealed Friday afternoon that it lost an arbitration dispute with Daiichi Sankyo relating to the companies’ 2008 collaboration around the use of antibody-drug conjugate (ADC) technology.

But that loss likely won’t matter much when it comes to Merck’s deal.

After breaking off its pact with Daiichi in mid-2015, the two companies battled over “linker” tech — a chemical bridge between an ADC’s antibody component and the cytotoxic payload — that Seagen claims Daiichi would improve upon and implement in its current generation of ADCs.

Ab­bott pumps $450M+ in­to new Ire­land-based man­u­fac­tur­ing site project and hir­ing spree

As Ireland continues to see more investments and building projects from pharma companies, another contender is looking to place more investment in the Emerald Isle.

According to a report from The Irish Times on Friday, Abbott Laboratories is investing €440 million, or about $451 million, to build a new manufacturing plant in Kilkenny, located in the country’s southeast, to make more of its glucose monitors.

Tony Coles, Cerevel CEO

Cerev­el takes the pub­lic of­fer­ing route, with a twist — rais­ing big mon­ey thanks to ri­val da­ta

As public biotechs seek to climb out of the bear market, a popular strategy to raise cash has been through public offerings on the heels of positive data. But one proposed raise Wednesday appeared to take advantage not of a company’s own data, but those from a competitor.

Cerevel Therapeutics plans to raise $250 million in a public offering and another $250 million in debt, the biotech announced Wednesday afternoon, even though it did not report any news on its pipeline. However, the move comes days after rival Karuna Therapeutics touted positive Phase III data in schizophrenia, a field where Cerevel is pursuing a similar program.

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Andy Kidd, Aptinyx CEO

‘The place­bo caught up’: Months af­ter di­a­bet­ic nerve pain fail, Aptinyx sees an­oth­er pain tri­al fall through

In 2019, Aptinyx’s stock cratered after it reported that its lead candidate failed a diabetic nerve pain trial. After some ‘further analysis,’ the biotech re-upped with that same non-opioid pain drug in two more mid-stage studies — another diabetic nerve pain trial and later a fibromyalgia trial.

In April, Aptinyx reported that its second diabetic nerve pain trial also fell through. However, the Illinois-based penny stock biotech had one more shot for its NMDA-modulating drug, dubbed NYX-2925, in fibromyalgia.

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