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Senate Drug Pricing Hearing Looms As Unparalleled Event For Pharma
BioMarin CEO Suggests Hemophilia Gene Therapy Pricing In $2m-$3m Range
During BioMarin’s earnings call Feb. 21, CEO Bienaime indicated the company may be looking to price its valoctocogene roxaparvovec gene therapy at $2m-$3m, as it would represent a savings over the annual cost of infused clotting factor therapy.
Pipeline Watch: Phase III Readouts For Tanezumab, Obeticholic Acid
Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.
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Recent Tweets from ScripPulse Of The Industry 2018: How Medtechs Will Create Value In The New Health Ecosystem
In the 12th edition of EY’s medtech report, The Pulse of the Industry, they examine the annual performance of the medical device industry in the context of the technological advances and rising customer expectations associated with the Fourth Industrial Revolution. To thrive in this transformative age, medtechs must adapt their business models to meet the increased expectations of consumers and other health care stakeholders.
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Another Botox Competitor: Revance Prepares Longer-Lasting RT002 For BLA Submission
A claim that RT002's duration of efficacy surpasses the leading neurotoxin – Allergan's blockbuster Botox – will be put to the test when Revance seeks US FDA approval to treat frown lines in the first half of this year. The company's Botox biosimilar with Mylan also could move forward in 2019.
Obituary: Indian Generics Industry Torchbearer Dilip Shah
Indian industry veteran and secretary general of the Indian Pharmaceutical Alliance, Dilip Shah, has died aged 77. Shah, a former commercial director of Pfizer in India, played a pivotal role in ensuring that the Indian generic industry's voice was heard.
The HOX Hypothesis: A Novel Approach To Targeted Cancer Therapy
Emerging Company Profile: With a Phase I clinical trial starting in Q3 and Series A funding to raise, HOX Therapeutics is taking a step out of the shadows of academia to develop its novel drug candidates in brain and prostate cancer. CEO Karl Keegan spoke to Scrip about what is next for the UK company.
Merck Strengthening Vaccine Capabilities By Acquiring Troubled Immune Design
Recently battered by clinical setbacks, Immune Design has a co-development partnership with Merck around Keytruda and Merck’s Perlmutter is a former board member. Merck would pay roughly $300m to acquire the company and its immune system-boosting technologies.
MPM Raises $400m To Build Early-Stage Biotechs
The venture capitalist builds biotechs from scratch and with this latest fund, MPM is looking to add to its sector-leading record of 49 FDA-approved drugs and over 100 IPOs and acquisitions.
GSK’s Terrell On ‘Relentless’ Digital Consumption Across the Spectrum
GSK’s first chief digital and technology officer shares with Scrip her views on things digital that could potentially transform the pharmaceutical business, the ex-Walmart executive noting how digital touch points with physicians are improving “in every single geography and every single product.”
Tough Going Forces Chinese Biotechs To Form Domestic Alliances
Deals among domestic Chinese biotechs are growing fast, reflecting a need to huddle up amid tightening scrutiny over biotech deal-making and an unusually competitive immuno-oncology market.
Cipla Backs Start-Up As It Builds Digital Health Strategy
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Cell Therapies Forge Ahead In Japan with Reimbursement, Approval Decisions
A controversial cell therapy for spinal injuries receives coverage under Japan’s national health scheme, amid signs that the pricing of regenerative therapies may come under more scrutiny, while the first CAR-T treatment in the country takes a step closer to market.
Sanofi Releases Annual Drug Price Report Ahead Of Senate Hearing
Sanofi's annual report on its drug price increases echoed a theme heard during recent 2018 earnings calls, with list price hikes offset by rebates resulting in a net price decline.
Mortality Signal For Pfizer's Xeljanz In Rheumatoid Arthritis Puts A Damper On JAK Class
Analyst speculates that risk of pulmonary embolism for a higher unapproved dose of Xeljanz in arthritis could trigger a label change for the same regimen in the drug's ulcerative colitis indication.
Novo Nordisk CSO: Hemophilia Treatment ‘Segmenting’ Much Like In Diabetes
Novo Nodisk's CSO says FDA approval of extended half-life Factor VIII Esperoct treatment for people with hemophilia A will give more choice to those patients and "effectively completes" the Danish group's hitherto R&D efforts based on clotting factor deficiencies.
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Modus CEO On Its Plans For An At-Home Injectable For Sickle Cell Crises
Modus Therapeutics has begun a Phase I study with subcutaneously administered sevuparin. Its CEO says this new formulation of its lead asset has the potential to be self-administered by sickle cell disease patients at home for the treatment of vaso-occlusive crises.
Korea IND Filing Moves Alteogen's Eylea Biosimilar Forward
South Korean biotech Alteogen is progressing the development of its Eylea biosimilar both at home and abroad, with the hope of becoming a global first mover with its version in wet AMD, backed by formulation and manufacturing patents.
ReNeuron's Cell Therapy Garners Excitement In RP-Related Vision Loss
A surprisingly strong improvement in vision has accompanied the use of proprietary stem cells in the first three retinitis pigmentosa patients in a US Phase II study, intriguing the UK biotech, ReNeuron, and maybe attracting development partners too.
Reata Expands Options For Bardoxolone With New CKD Data
Once suspended due to safety issues, bardoxolone now has completed a Phase II study that showed kidney function benefit in four rare types of CKD. A pivotal study is underway, with another planned and more possible.
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