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Pharmaceutical Business Review

AstraZeneca, Harvard Stem Cell Institute enter five-year diabetes research collaboration AstraZeneca has signed a five-year collaboration deal with the Harvard Stem Cell Institute (HSCI), under which the parties will investigate adapting a technique to create human beta cells from stem cells for use in finding new treatments for diabetes. Contract Research & Services > Contract Research > News
GSK's COPD treatment Encruse Ellipta gets Japanese approval By PBR Staff Writer
GlaxoSmithKline (GSK) has received approval from the Japanese Ministry of Health, Labour and Welfare (MHLW) for Encruse Ellipta (umeclidinium) for the relief of various symptoms due to airway obstruction with chronic obstructive pulmonary diseases (COPD).
News Signum out-licenses SIG990 to Dermata to develop new topical treatment for rosacea By PBR Staff Writer
US-based biotechnology firm Signum Dermalogix has out-licensed SIG990, a new anti-inflammatory compound, to Dermata Therapeutics for the development of a topical product to treat patients with rosacea, a chronic skin condition.
News Teikoku gets FDA acknowledgment of receipt for Docetaxel Injection By PBR Staff Writer
Teikoku Pharma USA (TPU) has received an acknowledgment of the receipt from the US Food and Drug Administration (FDA) for a 505(b)(2) new drug application (NDA) for Docetaxel Injection Concentrate, Non-Alcohol Formula.
News
FDA approves Sanofi Pasteur's Quadracel vaccine for children four to six years of age By PBR Staff Writer
Vaccines division Sanofi Pasteur has secured approval from the US Food and Drug Administration (FDA) to use Quadracel vaccine for active immunization against diphtheria, tetanus, pertussis and poliomyelitis in children four through six years of age.
News FDA grants orphan drug status for CymaBay's MBX-8025 to treat HoFH By PBR Staff Writer
The US Food and Drug Administration (FDA) has granted orphan drug designation for CymaBay Therapeutics' MBX-8025, a potent and selective peroxisome proliferator-activated receptor delta (PPARδ) agonist, to treat homozygous familial hypercholesterolemia (HoFH), an autosomal genetic disease.
News Marinus gets FDA orphan drug status for ganaxolone to treat PCDH19 female epilepsy By PBR Staff Writer
Marinus Pharmaceuticals has received orphan drug designation from the US Food and Drug Administration (FDA) for ganaxolone, a synthetic analog of the endogenous neurosteroid allopregnanolone, to treat protocadherin 19 gene (PCDH19) female epilepsy.
News

Latest News and Insight by Sector

Production & Manufacturing

Pharmax launches HLC Baby B and HLC Baby F probiotic supplements
By PBR Staff Writer
Pharmax, a business unit of Atrium Innovations, has introduced its new HLC Baby B and HLC Baby F probiotic supplements.
News
Biohaven enters into license deal for Catalent's Zydis ODT technology
By PBR Staff Writer
Biohaven Pharmaceutical (Biohaven) has entered into an exclusive world-wide agreement with Catalent Pharma Solutions for its Zydis Orally Disintegrating Tablet (ODT) technology to be used in the development of Biohaven's lead drug development candidate, BHV-0223.
News

Drug Research

GSK's COPD treatment Encruse Ellipta gets Japanese approval
By PBR Staff Writer
GlaxoSmithKline (GSK) has received approval from the Japanese Ministry of Health, Labour and Welfare (MHLW) for Encruse Ellipta (umeclidinium) for the relief of various symptoms due to airway obstruction with chronic obstructive pulmonary diseases (COPD).
News
Teikoku gets FDA acknowledgment of receipt for Docetaxel Injection
By PBR Staff Writer
Teikoku Pharma USA (TPU) has received an acknowledgment of the receipt from the US Food and Drug Administration (FDA) for a 505(b)(2) new drug application (NDA) for Docetaxel Injection Concentrate, Non-Alcohol Formula.
News

Inward Investment

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.
News
Merck in talks to acquire Cubist Pharmaceuticals for nearly $8bn
By PBR Staff Writer
New Jersey-based drug giant Merck & Co is, reportedly, in talks over a potential acquisition of antibiotics maker Cubist Pharmaceuticals for more than $8bn.
News

Packaging

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.
News
Bosch expands CPS portfolio for serialization of pharmaceutical packaging
Bosch Packaging Technology, a leading supplier of process and packaging technology, has expanded its portfolio for the serialization of pharmaceutical packaging. In the fight against counterfeit drugs, many countries are about to implement legislation changes for a stricter labelling of pharmaceuticals. Consequently, drug manufacturers require safer and more flexible solutions.
News

Contract Research & Services

Signum out-licenses SIG990 to Dermata to develop new topical treatment for rosacea
By PBR Staff Writer
US-based biotechnology firm Signum Dermalogix has out-licensed SIG990, a new anti-inflammatory compound, to Dermata Therapeutics for the development of a topical product to treat patients with rosacea, a chronic skin condition.
News
AstraZeneca, Harvard Stem Cell Institute enter five-year diabetes research collaboration
By PBR Staff Writer
AstraZeneca has signed a five-year collaboration deal with the Harvard Stem Cell Institute (HSCI), under which the parties will investigate adapting a technique to create human beta cells from stem cells for use in finding new treatments for diabetes.
News

Automation

GenVec, TheraBiologics to develop new cancer therapeutics
By PBR Staff Writer
US-based biopharmaceutical firm GenVec has entered into a collaboration agreement with TheraBiologics to develop neural stem cell mediated cancer therapies.
News
Takeda, Immunogen sign potential $440m drug development deal
By PBR Staff Writer
Japan-based Takeda Pharmaceutical Company and US-based ImmunoGen have signed a drug development agreement that could be worth more than $440m.
News

Regulatory Affairs

FDA grants orphan drug status for CymaBay's MBX-8025 to treat HoFH
By PBR Staff Writer
The US Food and Drug Administration (FDA) has granted orphan drug designation for CymaBay Therapeutics' MBX-8025, a potent and selective peroxisome proliferator-activated receptor delta (PPARδ) agonist, to treat homozygous familial hypercholesterolemia (HoFH), an autosomal genetic disease.
News
Marinus gets FDA orphan drug status for ganaxolone to treat PCDH19 female epilepsy
By PBR Staff Writer
Marinus Pharmaceuticals has received orphan drug designation from the US Food and Drug Administration (FDA) for ganaxolone, a synthetic analog of the endogenous neurosteroid allopregnanolone, to treat protocadherin 19 gene (PCDH19) female epilepsy.
News



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