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Pfizer, Lilly’s osteoarthritis pain drug meets co-primary endpoints in phase 3 study Pfizer and Eli Lilly’s osteoarthritis (OA) pain drug, tanezumab, has met all three co-primary endpoints in a phase 3 study. Contract Research & Services > Clinical Trials > News
FDA accepts Immunomedics’ BLA and grants priority review for Sacituzumab Govitecan to treat metastatic triple-negative breast cancer Immunomedics announced that the US Food and Drug Administration (FDA) has accepted its biologics license application (BLA) for filing and granted priority review for sacituzumab govitecan for the treatment of patients with metastatic triple-negative breast cancer (mTNBC) who previously received at least two prior therapies for metastatic disease.
News Takeda, Ovid plan to launch three trials of anti-epileptic drug TAK-935/OV935 Takeda Pharmaceutical and Ovid Therapeutics have revealed details of a clinical development program of their anti-epileptic drug TAK-935/OV935 in rare developmental and epileptic encephalopathies (DEE).
Contract Research & Services > Clinical Trials > News Pfizer, Lilly’s osteoarthritis pain drug meets co-primary endpoints in phase 3 study By PBR Staff Writer
Pfizer and Eli Lilly’s osteoarthritis (OA) pain drug, tanezumab, has met all three co-primary endpoints in a phase 3 study.
Contract Research & Services > Clinical Trials > News
Eureka Therapeutics announces Boehringer Ingelheim is exercising option to license novel TCRm) antibodies Eureka Therapeutics announced that Boehringer Ingelheim has elected to exercise an option for the exclusive license of novel human TCR-mimicking (TCRm) antibodies against an undisclosed target to be used for the potential development and commercialization of therapies for cancer patients.
Drug Research > Drug Discovery & Development > News Clinigen acquires global rights to Proleukin outside US Clinigen Group has acquired the global rights to Proleukin (aldesleukin, recombinant interleukin-2) outside the United States from Novartis.
Production & Manufacturing > Manufacturing > News Roche’s baloxavir marboxil succeeds in phase III flu study By PBR Staff Writer
A phase III CAPSTONE-2 study has demonstrated that baloxavir marboxil reduced symptoms in people at high risk of complications from the flu.
Contract Research & Services > Clinical Trials > News

Latest News and Insight by Sector

Production & Manufacturing

Clinigen acquires global rights to Proleukin outside US
Clinigen Group has acquired the global rights to Proleukin (aldesleukin, recombinant interleukin-2) outside the United States from Novartis.
Production & Manufacturing > Manufacturing > News
Genentech seeks FDA approval for Venclexta for AML
Roche’s Genentech has submitted a supplemental New Drug Application (sNDA) to the US Food and Drug Administration (FDA) for Venclexta (venetoclax), in combination with either a hypomethylating agent or low dose cytarabine (LDAC), for the treatment of acute myeloid leukemia (AML) in previously untreated patients who are ineligible for intensive chemotherapy.
Production & Manufacturing > Process & Production > News

Drug Research

Eureka Therapeutics announces Boehringer Ingelheim is exercising option to license novel TCRm) antibodies
Eureka Therapeutics announced that Boehringer Ingelheim has elected to exercise an option for the exclusive license of novel human TCR-mimicking (TCRm) antibodies against an undisclosed target to be used for the potential development and commercialization of therapies for cancer patients.
Drug Research > Drug Discovery & Development > News
Taiho Pharmaceutical exercises option to develop AB928 in its territories
Arcus Biosciences announced that Taiho Pharmaceutical has exercised its option to obtain an exclusive development and commercialization license to the company’s adenosine receptor antagonist program, which includes AB928 and back-up compounds, in Japan and certain other territories in Asia (excluding China).
Drug Research > Drug Discovery & Development > News

Inward Investment

New WuXi Life Science to acquire WuXi PharmaTech for $3.3bn
Shanghai-based WuXi PharmaTech has entered into a merger agreement with New WuXi Life Science and its wholly owned subsidiary WuXi Merger, worth a total cash consideration of $3.3bn.
Inward Investment > News
PPF Group acquires minority stake in Cytune Pharma
By PBR Staff Writer
PPF Group, in cooperation with SOTIO has completed acquisition of minority stake in French biotechnology firm Cytune Pharma.
Inward Investment > News

Packaging

Catalent completes acquisition of Australia's Pharmapak
By PBR Staff Writer
US-based Catalent Pharma Solutions has strengthened its ability to provide integrated solutions to customers with the acquisition of Pharmapak Technologies, an Australian pharmaceutical packaging business.
Production & Manufacturing > OTC > News
MP Global Products introduces foam-free packaging for shipment of temperature sensitive pharmaceuticals
MP Global Thermal Packaging Products insulated protective mailers and box liners are specifically designed for temperature control and protection of mail order shipments of temperature sensitive pharma, pet meds, and natural and organic cosmetics.
Packaging > News

Contract Research & Services

Takeda, Ovid plan to launch three trials of anti-epileptic drug TAK-935/OV935
Takeda Pharmaceutical and Ovid Therapeutics have revealed details of a clinical development program of their anti-epileptic drug TAK-935/OV935 in rare developmental and epileptic encephalopathies (DEE).
Contract Research & Services > Clinical Trials > News
Pfizer, Lilly’s osteoarthritis pain drug meets co-primary endpoints in phase 3 study
By PBR Staff Writer
Pfizer and Eli Lilly’s osteoarthritis (OA) pain drug, tanezumab, has met all three co-primary endpoints in a phase 3 study.
Contract Research & Services > Clinical Trials > News

Automation

Horizon Discovery out-licenses cell line engineering technology to US firm
Horizon Discovery Group has entered into a non-exclusive out-licensing agreement with an undisclosed US-based immuno-oncology company (the Partner) for its technologies to support the development and manufacture of a biomanufacturing cell line for commercial use.
Automation > IT & Software > News
GE to provide biomanufacturing platform for Clover’s Chinese facility
By PBR Staff Writer
GE Healthcare will provide its biomanufacturing platform for Clover Biopharmaceuticals’ new production facility in China.
Automation > IT & Software > News

Regulatory Affairs

FDA accepts Immunomedics’ BLA and grants priority review for Sacituzumab Govitecan to treat metastatic triple-negative breast cancer
Immunomedics announced that the US Food and Drug Administration (FDA) has accepted its biologics license application (BLA) for filing and granted priority review for sacituzumab govitecan for the treatment of patients with metastatic triple-negative breast cancer (mTNBC) who previously received at least two prior therapies for metastatic disease.
News
Indivior wins US court order blocking Dr. Reddy's sale of generic opioid treatment
By PBR Staff Writer
A US court has approved Indivior’s preliminary injunction (PI) preventing Dr. Reddy's Laboratories (DRL) from marketing of generic opioid addiction treatment.
Regulatory Affairs > News



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