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Commercial

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All Eyes On Pfizer For More Details On COVID-19 Vaccine Launch

Pfizer's COVID-19 vaccine is sure to dominate the third quarter results call, with everything from data to widescale distribution and the potential financial reward on the minds of investors and the public.

Sales & Earnings Companies Commercial

With $850m, Nuvation Aims To Speed Novel Cancer Drugs To Patients

Nuvation started in 2018 and raised a $275m series A round in 2019. Now it is merging with the EcoR1 Capital-sponsored SPAC Panacea Acquisition Corp. and raising $500m in equity capital.

Financing Deals Cancer

Companies

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Latest From Companies

Coronavirus Update: Gilead's Veklury Gets Full FDA Approval, Roche Partners With Atea

Gilead's remdesivir is first drug fully approved by FDA to treat COVID-19. Roche and Atea team up on an investigational direct acting antiviral while Moderna reaches the 30,000-patient enrollment target for its Phase III COVE study of the company's investigational mRNA vaccine. 

Coronavirus COVID-19 Vaccines

Vifor Confident About Prospects For Pruritus Dialysis Drug Korsuva

Vifor CEO Stefan Schulze tells Scrip that an expanded deal with Korsuva developer Cara Therapeutics means the US biotech will not have to invest in a commercial organization as the Swiss firm will mobilize its well-established sales force to launch the treatment for dialysis patients with CKD-associated pruritus.

Deals Renal

Is Biogen’s Aducanumab Approvable? Opinions Divided Ahead Of Review

Many clinicians doubt that aducanumab can really help slow the decline in Alzheimer’s patients – but  US FDA could offer it the benefit of the doubt.

Commercial Companies

Aptinyx To Forge Ahead With Pivotal PTSD Study

Positive Phase II data for Aptinyx’s novel NMDA receptor modulator are strong enough to take the product into a pivotal study in this difficult-to-treat area.

Clinical Trials Companies

Stockwatch: Pandemic And Biosimilar Effects Subordinate Early Third-Quarter Earnings Results

Early in 2020, company guidance was that pandemic-related effects would have dissipated in the third quarter. Issues specific to J&J and Roche leave this broad conclusion still up in the air.

Stockwatch Commercial

Asia Executives On The Move: Sanofi's Global R&D Head Moves To Innovent

Recent moves show Chinese biotech firms are increasingly looking to go global by recruiting world-class development talent, and J&J names new APAC pharma head.

Appointments China
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Deals

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Finance Watch: A SPACtacular Week For Biopharma Deals And Dollars

Public Company Edition: Four health care special purpose acquisition vehicles went public and two others announced mergers, but only one biopharma firm priced an IPO during the week of 19-23 October. Replimune’s $250m offering led recent FOPOs.

Financing Deals

Ultragenyx Enters Duchenne Gene Therapy Space In $295m Deal With Solid Biosciences

Ultragenyx enters a competitive and complicated market, but the combination of its manufacturing platform with Solid’s transgene could provide an advantage. 

Deals Gene Therapy

Retrophin Bolsters Portfolio With Orphan Technologies Buyout

The rare disease-focused firm will pay $90m up front to acquire Orphan Technologies and its Phase I/II enzyme replacement therapy for homocystinuria. Earnouts up to $427m are possible as well.

Deals M & A

Coronavirus Update: Gilead's Veklury Gets Full FDA Approval, Roche Partners With Atea

Gilead's remdesivir is first drug fully approved by FDA to treat COVID-19. Roche and Atea team up on an investigational direct acting antiviral while Moderna reaches the 30,000-patient enrollment target for its Phase III COVE study of the company's investigational mRNA vaccine. 

Coronavirus COVID-19 Vaccines

Vifor Confident About Prospects For Pruritus Dialysis Drug Korsuva

Vifor CEO Stefan Schulze tells Scrip that an expanded deal with Korsuva developer Cara Therapeutics means the US biotech will not have to invest in a commercial organization as the Swiss firm will mobilize its well-established sales force to launch the treatment for dialysis patients with CKD-associated pruritus.

Deals Renal

Voronoi’s Brain-Permeable NSCLC Candidate Attracts ORIC To Major Deal

Through a licensing-out deal with ORIC for its EGFR/HER2 exon-20 inhibitor, South Korea's Voronoi hopes to gain from its new partner's commercialization experience in NSCLC. The alliance aims to build a potentially best-in-class presence in a competitive landscape.

Cancer South Korea
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Strategy

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Latest From Strategy

Novartis Takes Huntington's Path With SMA Therapy Branaplam

With Roche's oral spinal muscular atrophy therapy Evrysdi off to a strong start after its recent US launch, Novartis is switching its priorities for rival RNA-splicing drug branaplam and putting it into a Phase IIb trial for Huntington's disease.

Neurology Clinical Trials

Sanofi Touts Positive Dupixent Data For Severe Childhood Asthma

Dupixent is already is a big seller in severe asthma in adults and adolescents but Sanofi is looking to expand the label after presenting data showing that it is the only biologic in Phase III trial to have demonstrated improved lung function in children.

Respiratory Clinical Trials

Ireland's Priothera Raises €30m For Mocravimod in AML

Novartis passed up the chance for further development of Kyorin's mocravimod for autoimmune diseases but newly formed Priothera is evaluating the S1P receptor modulator for acute myeloid leukemia patients undergoing hematopoietic stem cell transplantation.

Financing Cancer

Pfizer And Sangamo Start Phase III Study For Hemophilia A Gene Therapy

The move into Phase III for giroctocogene fitelparvovec comes on the heels of BioMarin's surprise setback when the FDA demanded more proof of durability of its rival hemophilia A gene therapy Roctavian.

Blood & Coagulation Disorders Gene Therapy

Belgium's Argenx Advances On More Positive Efgartigimod Data

Argenx's efgartigimod, an antibody fragment that blocks FcRn, looks most likely to be the first drug to challenge Alexion's Soliris in the myasthenia gravis market after the company presented more positive data from the ADAPT trial.

Rare Diseases Clinical Trials

Major Milestone For Diurnal As FDA Approves Alkindi

The US green light for Alkindi is a big step for the UK biotech in its bid to become a world-leading specialty endocrinology business.

Approvals Rare Diseases
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Market Access

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Latest From Market Access

Vifor Confident About Prospects For Pruritus Dialysis Drug Korsuva

Vifor CEO Stefan Schulze tells Scrip that an expanded deal with Korsuva developer Cara Therapeutics means the US biotech will not have to invest in a commercial organization as the Swiss firm will mobilize its well-established sales force to launch the treatment for dialysis patients with CKD-associated pruritus.

Deals Renal

Moving Cell And Gene Therapies Into Chronic Conditions Depends On Durability, Safety

Biopharma executives discussed their strategies for treating chronic diseases during the Cell and Gene Meeting on the Mesa, including R&D and regulatory considerations.

Gene Therapy Regenerative Medicine

Roche Strikes Reality Note For Production Of Regeneron-Partnered COVID-19 Antibody Cocktail

Roche Pharma CEO Bill Anderson is excited about the prospects for REGN-COV2 but with the company and Regeneron possibly producing two million doses per year by the end of Q1 2021, meeting demand worldwide will be an impossible task.

Coronavirus COVID-19 Manufacturing
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Market Intelligence

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Latest From Market Intelligence

Heart Failure A Key Future Market For Jardiance?

Boehringer Ingelheim and Eli Lilly’s SGLT2 inhibitor Jardiance (empagliflozin) reduces cardiovascular deaths and hospitalizations in certain heart failure patients regardless of whether they have diabetes, and regulatory submissions are expected for the additional indication later this year.

Cardiovascular Clinical Trials

MyoKardia's Mavacamten 'Impressive' In Hypertrophic Cardiomyopathy

MyoKardia is building up its organization to prepare for commercialization of mavacamten, a potential first-in-class agent for obstructive hypertrophic cardiomyopathy.

Cardiovascular Clinical Trials

GSK To Address Multiple Myeloma With First-In-Class Blenrep In EU

The European Commission’s approval of GlaxoSmithKline’s Blenrep is one of the first major fruits of a refocused pipeline and development strategy at the big pharma company.

Approvals Cancer
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