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Pharmaceutical Business Review

Indivior wins US court order blocking Dr. Reddy's sale of generic opioid treatment A US court has approved Indivior’s preliminary injunction (IP) preventing Dr. Reddy's Laboratories (DRL) from marketing of generic opioid addiction treatment. Regulatory Affairs > News
Ironwood Pharmaceuticals starts Phase IIIb study of linaclotide in adult patients with IBS-C Ironwood Pharmaceuticals has started a phase IIIb clinical trial evaluating the efficacy and safety of linaclotide 290 mcg on multiple abdominal symptoms in addition to pain, including bloating and discomfort, in adult patients with irritable bowel syndrome with constipation (IBS-C).
Contract Research & Services > Clinical Trials > News Pfizer begins pivotal phase 3 program for investigational hemophilia B gene therapy Pfizer and Spark Therapeutics announced that Pfizer initiated a Phase 3 open-label, multi-center, lead-in study (NCT03587116) to evaluate the efficacy and safety of current factor IX prophylaxis replacement therapy in the usual care setting.
Contract Research & Services > Clinical Trials > 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 (IP) preventing Dr. Reddy's Laboratories (DRL) from marketing of generic opioid addiction treatment.
Regulatory Affairs > 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 Apotex to divest European generics business Apotex has signed an agreement to sell its commercial operations and certain supporting infrastructure for its generics business in five European countries to Aurobindo Pharma.
News SIGA Technologies gets FDA nod for TPOXX to treat smallpox By MDBR Staff Writer
SIGA Technologies has secured approval from the US Food and Drug Administration (FDA) for its TPOXX (tecovirimat) for the treatment of smallpox.
Regulatory Affairs > News

Latest News and Insight by Sector

Production & Manufacturing

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
Dermavant to buy rights to tapinarof from GSK for £250m
GSK announced that Dermavant Sciences, a subsidiary of Roivant Sciences, has agreed to purchase the rights to tapinarof, an investigational therapeutic aryl hydrocarbon receptor modulating agent (TAMA) for the treatment of psoriasis and atopic dermatitis and back-up programmes for a total consideration of £250m.
Production & Manufacturing > Manufacturing > News

Drug Research

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
Genmab, Immatics to develop next-generation bispecific cancer immunotherapies
By PBR Staff Writer
Genmab has signed a collaboration and exclusive license agreement with Immatics Biotechnologies to work on next-generation bispecific cancer immunotherapies.
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

Ironwood Pharmaceuticals starts Phase IIIb study of linaclotide in adult patients with IBS-C
Ironwood Pharmaceuticals has started a phase IIIb clinical trial evaluating the efficacy and safety of linaclotide 290 mcg on multiple abdominal symptoms in addition to pain, including bloating and discomfort, in adult patients with irritable bowel syndrome with constipation (IBS-C).
Contract Research & Services > Clinical Trials > News
Pfizer begins pivotal phase 3 program for investigational hemophilia B gene therapy
Pfizer and Spark Therapeutics announced that Pfizer initiated a Phase 3 open-label, multi-center, lead-in study (NCT03587116) to evaluate the efficacy and safety of current factor IX prophylaxis replacement therapy in the usual care setting.
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

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 (IP) preventing Dr. Reddy's Laboratories (DRL) from marketing of generic opioid addiction treatment.
Regulatory Affairs > News
SIGA Technologies gets FDA nod for TPOXX to treat smallpox
By MDBR Staff Writer
SIGA Technologies has secured approval from the US Food and Drug Administration (FDA) for its TPOXX (tecovirimat) for the treatment of smallpox.
Regulatory Affairs > News



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