All
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.
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.
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.
Tjoapack to Invest in Automated Injectables Packaging Capabilities
Tjoapack is investing in fully automated lines, including a PFS line with an initial capacity of 7 million syringes per year and a vial line with an eventual capacity of more than 12 million vials per year.
Takeda to Divest Non-Core Assets for $562 million
Takeda is divesting its portfolio of select, non-core prescription pharmaceutical products sold in Europe and Canada to Cheplapharm, a German pharmaceutical company.
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.
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.
ECCRT and IDDI Partner for Continuous Development
ECCRT and IDDI have established a partnership for the continuous development of IDDI global team members.
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.
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.
Evonik Qualifies Filling Line for Parenteral Drug Products at its Alabama Facility
The new line has the ability to aseptically fill powder, liquid, suspension, and combination forms into vials in clinical or commercial batch sizes.
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.
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.
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.
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.
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.
Stevanato and Nelson Labs Team Up to Provide E&L Testing
The companies have signed a partnership agreement to provide extractables and leachables testing at the SG US Technology Excellence Center in Boston, MA.
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.
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.
Leader of the Pack?
AstraZeneca has potentially taken poll position in the race to develop a novel coronavirus vaccine, but will AZD1222 be ready in 2020?
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.
