Industry News
Roquette Launches Next-Generation Direct Compression Solutions
Roquette has launched excipients PEARLITOL CR-H and PEARLITOL 200 GT.
Venture Capital Funding to Fuel Pharma Outsourcing
The CPHI Annual Report 2022 predicts cash reserves from venture capitalists and private equities will drive expansion in the demand for contract research organizations and contract development and research organizations.
FDA Approves AstraZeneca’s Imjudo for Combination Liver Cancer Treatment
AstraZeneca’s Imjudo (tremelimumab) was approved by FDA in combination with Imfinzi (durvalumab) for treating unresectable liver cancer.
Pressure Mounts for FDA to Reform Accelerated Approval Program
An advisory committee’s vote to remove Makena from the market illustrates how difficult it is for regulators to ensure that such drugs document safety and effectiveness in a timely manner.
Cambrex Announces Stability Storage Expansions in Ireland and Belgium
Cambrex has expanded its stability storage business, Q1 Scientific, in Ireland and Belgium.
AAPS to Provide Scientific Programming Oversight for Interphex
AAPS will exclusively advise RX Global on scientific focus areas for Interphex 2023, which is set to take place at the Javits Center in New York City next spring.
EMA Recommends Adapted Spikevax Vaccine
The agency has recommended authorization of the Spikevax COVID-19 vaccine that targets the Omicron variants BA.4 and BA.5.
EMA Extends Use of COVID-19 Vaccines to Children
The agency has recommended approval of Comirnaty and Spikevax for children from six months of age.
FDA Authorizes Bivalent COVID-19 Boosters for Children Ages Five and Older
FDA amended its authorization for the Moderna and Pfizer-BioNTech bivalent booster vaccines to permit their use in children as young as five years old.
CRB Releases Trends and Insights Report
CRB’s Horizons: Life Sciences report covers challenges facing manufacturers and how to keep pace with rapid innovation.
FDA Expands Oversight of Cell and Gene Therapies
CBER maps modernization plan to handle surge in research and applications.
UK Approves Treatment for Sleep Onset Insomnia in Children and Adolescents
The UK’s MHRA has approved Colonis’ melatonin oral solution for sleep onset insomnia in children and adolescents with ADHD.
H.I.G. Capital Acquires Morningside Healthcare and Morningside Pharmaceuticals
H.I.G. Capital’s portfolio company Aspire Pharma has acquired Morningside Healthcare and Morningside Pharmaceuticals.
FDA Grants Fast Track Designation to Cue Biopharma
FDA has granted Fast Track designation for CUE-101, a treatment of recurrent/metastatic head and neck squamous cell carcinoma.
Pfizer Completes Acquisition of Biohaven Pharmaceuticals
Pfizer has completed its acquisition of Biohaven Pharmaceuticals for approximately $11.6 billion.
PerkinElmer Unveils Cell Analysis Solution
PerkinElmer has unveiled a cell analysis solution to streamline cell and gene therapy research and manufacturing.
FDA Expands Patient Input on Drug Development
FDA is highlighting how the Patient-Focused Drug Development program has encouraged active involvement of many patient groups in bringing their perspectives into the process of developing, testing, and approving new medicines.
Biogen to Settle Kickbacks Lawsuit for $900 Million
Biogen has agreed to pay $900 million to settle federal and state claims that it paid kickbacks to physicians to encourage them to prescribe its drugs.
Novel Imaging Approach Reveals Key Details About Rare Eye Disease
A combination of eye imaging techniques and adaptive optics has revealed key details of choroideremia.
Actylis Debuts as an Integrated Global Specialty Ingredients Manufacturing and Sourcing Provider
Actylis combines Aceto and its 10 acquired specialists into a singular global brand.
Pfizer to Supply up to 6 Million PAXLOVID Treatment Courses for Low-and-Middle-Income Countries
Pfizer is set to supply global fund up to 6 million treatment courses of its COVID-19 oral treatment, PAXLOVID, for low-and-middle-income countries.
Congress Slated to Reauthorize User Fees Without FDA “Improvements”
Legislative leaders are looking to approve a bare-bones measure to fund FDA operations as part of a short-term government funding bill.
FDA and NIH Enter Rare Neurodegenerative Diseases Partnership
The Public-Private Partnership for Rare Neurodegenerative Diseases will work to enhance understanding and develop treatments for rare neurodegenerative diseases.
Lonza Expands HPAPI Multipurpose Suite
Lonza has expanded its HPAPI multipurpose suite for payload-linker manufacturing.
Clinical Trial Modernization Raises FDA Compliance Issues
Regulatory officials are addressing challenges in ensuring that clinical data can be relied on in making regulatory decisions.
CytoReason Announces Expanded Collaboration Deal with Pfizer
CytoReason has announced an expanded collaboration deal with Pfizer to deliver AI for drug discovery and development.
Civica to Invest $27.8 Million in New Testing Facility
Civica is expanding in the greater Richmond-Petersburg region and investing $27.8 million in a new testing facility.
Novo Nordisk and Microsoft Collaborate to Accelerate Drug Discovery and Development
Novo Nordisk and Microsoft are collaborating to accelerate drug discovery and development using big data and artificial intelligence.
Ensysce Biosciences and Quotient Sciences Announce Partnership
Ensysce Biosciences and Quotient Sciences are partnering to develop and test Ensysce’s novel opioid designed to prevent abuse and overdose.
EMA Recommends Approval of Enjaymo
EMA has recommended approval of Enjaymo for the treatment of hemolytic anemia in adult patients with cold agglutinin disease.
