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Merck Announces Two Oncology Collaborations with Seattle Genetics
The companies will focus on the development and commercialization of Seattle Genetics’ ladiratuzumab vedotin and TUKYSA (tucatinib).
Cytiva Invests $500 Million Over 5 years to Expand Global Capacity
The investment will include new manufacturing lines and increased automation to deliver additional manufacturing capacity.
Trump Escalates Drug Pricing War
The White House issued an executive order Sunday, Sept. 13, 2020 implementing a policy to link payments for medicines provided through Medicare to prices charged in other industrial countries.
Vectura and Monash University to Develop Inhaled Oxytocin for the Prevention of Postpartum Hemorrhage
Vectura will support the product from Phase I through to commercial launch.
Gilead to Acquire Immunomedics for $21 Billion
The acquisition will give Gilead access to an anti-cancer antibody drug conjugate in clinical development for treating breast and bladder cancers.
FDA Gives Guidance on Manufacturing During COVID-19
The temporary guidance discusses the resumption of normal manufacturing during the COVID-19 pandemic.
AZD1222 Clinical Trials Resume in the UK
Clinical trials for AZD1222 coronavirus vaccine resume in the UK as per guidance by MHRA.
Career FDA Leaders Say Science Is Agency’s Guide
In an opinion article, FDA leaders commit to applying “the best science” to approval decisions.
AstraZeneca Gains EU Approval for Imfinzi to Treat ES-SCLC
Imfinzi has been granted approval in the EU for the treatment of adults with extensive-stage small cell lung cancer.
CPhI Releases Virtual Event Agenda
CPhI has released the agenda for its forthcoming two-week virtual event, CPhI Festival of Pharma.
Cobra and CombiGene Sign Agreement for Plasmid Production for Gene Therapy
The companies have signed an agreement for the production of two plasmids needed for the manufacture of CG01, a gene therapy for the treatment of drug-resistant focal epilepsy.
ECCRT and IDDI Partner for Continuous Development
ECCRT and IDDI have established a partnership for the continuous development of IDDI global team members.
PRAC Recommends Marketing Authorization of Ulipristal Acetate be Revoked
PRAC has recommended the marketing authorization of ulipristal acetate for the treatment of uterine fibroids be revoked.
MilliporeSigma Invests $65 Million to Expand Antibody-Drug Conjugate Manufacturing
The investment at its Madison, WI, facility will expand MilliporeSigma’s capacity for high-potent active pharmaceutical ingredient production and allow for continuous flow manufacturing of ADCs.
Catalent Invests $130 Million to Expand Gene Therapy Manufacturing Capacity
The company is investing $130 million to add Phase III through commercial-scale manufacturing suites to its gene therapy campus in Harmans, MD.
Thermo Fisher to Open a New Bioprocessing Collaboration Center in St. Louis, MO
The new facility will be adjacent to Thermo Fisher’s newly expanded biologics manufacturing facility.
Catalent and Exelixis to Collaborate on ADC Development
Catalent’s Redwood Bioscience subsidiary will develop antibody-drug conjugates (ADCs) for Exelixis using Catalent’s proprietary SMARTag site-specific bioconjugation technology.
AMRI Signs Agreement with AstraZeneca for COVID-19 Vaccine Delivery
AMRI will provide AstraZeneca with manufacturing capacity and sterile fill/finish services at its drug product manufacturing facility in Albuquerque, NM.
AES Introduces a New Pre-Designed Cleanroom Solution
The Faciliflex Express product line can be commissioned in six months, making it ideal for cell and gene therapy companies that need to rapidly bring their therapies to patients.
AstraZeneca Pauses Clinical Trial on COVID-19 Vaccine for Safety Review
The clinical trials of the AstraZeneca Oxford COVID-19 vaccine, AZD1222, have been paused for a safety review as a result of an incident of an unexplained illness in a UK trial patient.
FDA’s “Gold Standard” Critical for Biopharma R&D
Industry leaders insist they will maintain high standards for clinical trials and regulatory submissions for new vaccines and therapeutics to combat COVID-19.
Vaccine Developers Pledge to Stand with Science
As public confidence in the drug development process waivers, leading vaccine developers promise to adhere to scientific and regulatory principles.
Alcami to Provide Manufacturing Services for Trevena’s Pain Management Injection
Alcami will provide services for Trevena’s OLINVYK (oliceridine) injection, an opioid approved for the management of acute pain severe enough to require an intravenous opioid analgesic in adults.
BIO Message: Keep Drug Development Independence
BIO leaders urge biopharmaceutical companies to apply scientific principles in seeking drug and vaccine approvals.
Daré Bioscience and Avomeen Partner to Advance Women’s Health Programs
Avomeen will offer contract product development laboratory services to support the advancement of Daré’s innovative pipeline of investigational products dedicated to women’s health.
HJB and Ansun Biopharma Partner on Biologics CMC Development and Manufacturing
The companies have entered into a strategic partnership for the CMC development and manufacturing of Ansun’s biologics pipeline.
Kohlberg and Mubadala to Acquire Majority Stake in PCI Pharma Services
The companies have signed a definitive agreement to acquire a majority stake of PCI Pharma Services.
Sanofi, Regeneron Halt Development of Kevzara as a Potential COVID-19 Treatment
The companies provided an update stating that the biologic did not meet a primary endpoint in a Phase III clinical trial when compared with placebo in the treatment of COVID-19 patients.
iBio and Planet Biotechnology Partner to Develop COVID-19 Therapeutic
The companies will collaborate on the production of a novel anti-SARS-CoV-2 immunoadhesin in iBio’s FastPharming manufacturing system.
Catalent Invests $50 Million into High-Speed Filling Line at its Bloomington Site
The new line will add capacity to Catalent’s pipeline of clinical programs and commercial launches at the site.
