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Pharmaceutical Business Review

Catalent to acquire Indiana-based CDMO Cook Pharmica for $950m Catalent has agreed to acquire Indiana-based contract development and manufacturing organization (CDMO) Cook Pharmica for $950m to consolidate its position in the bio-pharma sector. Production & Manufacturing > Manufacturing > News
Pfizer announces outcome of FDA's ODAC meeting for SUTENT in patients at high risk of recurrent renal cell carcinoma after surgery Pfizer announced that the US Food and Drug Administration’s (FDA) Oncologic Drug Advisory Committee (ODAC) voted 6 in favor and 6 against the benefit-risk profile for SUTENT® (sunitinib) as adjuvant treatment of adult patients at high risk of recurrent renal cell carcinoma (RCC) after nephrectomy (surgical removal of the cancer-containing kidney).
Regulatory Affairs > News Ipsen gets EC approval for Xermelo to treat carcinoid syndrome diarrhea Ipsen announced that the European Commission (EC) has approved Xermelo (telotristat ethyl) 250 mg three times a day (tid) for the treatment of carcinoid syndrome diarrhea in combination with somatostatin analogue (SSA) therapy in adults inadequately controlled by SSA therapy.
News GSK, Innoviva get FDA nod for COPD treatment Trelegy Ellipta By PBR Staff Writer
GlaxoSmithKline (GSK) and Innoviva have secured approval from the US Food and Drug Administration (FDA) for once-daily and single inhaler triple therapy, Trelegy Ellipta, to treat patients with chronic obstructive pulmonary disease (COPD).
Regulatory Affairs > News
Catalent to acquire Indiana-based CDMO Cook Pharmica for $950m By PBR Staff Writer
Catalent has agreed to acquire Indiana-based contract development and manufacturing organization (CDMO) Cook Pharmica for $950m to consolidate its position in the bio-pharma sector.
Production & Manufacturing > Manufacturing > News FDA grants orphan drug status for Motif Bio’s Staphylococcus Aureus lung treatment The US Food and Drug Administration (FDA) has granted Motif Bio's investigational drug candidate, iclaprim, orphan drug designation to treat of Staphylococcus aureus lung infections in patients with cystic fibrosis.
Regulatory Affairs > News Ultragenyx proposes to acquire Dimension Therapeutics By PBR Staff Writer
Ultragenyx Pharmaceutical has made a proposal to acquire all of the outstanding shares of common stock of Dimension Therapeutics for $5.50 per share, or approximately $138m, in cash at close to be effectuated via a tender offer.
Drug Research > Drug Discovery & Development > News

Latest News and Insight by Sector

Production & Manufacturing

Catalent to acquire Indiana-based CDMO Cook Pharmica for $950m
By PBR Staff Writer
Catalent has agreed to acquire Indiana-based contract development and manufacturing organization (CDMO) Cook Pharmica for $950m to consolidate its position in the bio-pharma sector.
Production & Manufacturing > Manufacturing > News
CHMP recommends GSK, Innoviva’s single inhaler triple therapy for COPD
By PBR Staff Writer
GlaxoSmithKline (GSK) and Innoviva announced that a committee of the European Medicines Agency (EMA) has adopted positive opinion for fluticasone furoate/ umeclidinium/vilanterol (FF/UMEC/VI) in treating chronic obstructive pulmonary disease (COPD) in adults.
Production & Manufacturing > Process & Production > News

Drug Research

Ultragenyx proposes to acquire Dimension Therapeutics
By PBR Staff Writer
Ultragenyx Pharmaceutical has made a proposal to acquire all of the outstanding shares of common stock of Dimension Therapeutics for $5.50 per share, or approximately $138m, in cash at close to be effectuated via a tender offer.
Drug Research > Drug Discovery & Development > News
Mustang Bio announces expansion of CAR T pipeline into CD20-directed immunotherapies
Mustang Bio, a Fortress Biotech company, has announced the expansion of its pipeline of CAR T therapies into CD20-directed 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

Roche says Venetoclax combination improves PFS in phase III CLL trial
By PBR Staff Writer
Roche has reported that its cancer drug Venclexta/Venclyxto (venetoclax), developed jointly with AbbVie, has succeeded in a phase 3 study in chronic lymphocytic leukaemia (CLL) patients by meeting its primary endpoint.
Contract Research & Services > Clinical Trials > News
Bydureon EXSCEL trial shows favorable cardiovascular safety profile in patients with type-2 diabetes
AstraZeneca has announced full results from the EXSCEL (EXenatide Study of Cardiovascular Event Lowering) trial that showed cardiovascular safety with Bydureon (exenatide extended-release) in patients with type-2 diabetes (T2D) at a wide range of CV risk.
Contract Research & Services > Clinical Trials > News

Automation

Broad Institute of MIT and Harvard joins discussions to create global CRISPR-Cas9 licensing pool
The Broad Institute of MIT and Harvard has joined discussions to form a non-exclusive CRISPR-Cas9 joint licensing pool coordinated by MPEG LA, an organization that operates patent pool licensing programs in various institutions and countries.
Automation > IT & Software > News
Servier, Transgene to apply viral vectorization technology to engineering of allogenic CAR-T
Servier and Transgene have signed a research agreement on the application of viral vectorization technology for the production of allogenic CAR-T cell therapies.
Automation > IT & Software > News

Regulatory Affairs

Pfizer announces outcome of FDA's ODAC meeting for SUTENT in patients at high risk of recurrent renal cell carcinoma after surgery
Pfizer announced that the US Food and Drug Administration’s (FDA) Oncologic Drug Advisory Committee (ODAC) voted 6 in favor and 6 against the benefit-risk profile for SUTENT® (sunitinib) as adjuvant treatment of adult patients at high risk of recurrent renal cell carcinoma (RCC) after nephrectomy (surgical removal of the cancer-containing kidney).
Regulatory Affairs > News
Ipsen gets EC approval for Xermelo to treat carcinoid syndrome diarrhea
Ipsen announced that the European Commission (EC) has approved Xermelo (telotristat ethyl) 250 mg three times a day (tid) for the treatment of carcinoid syndrome diarrhea in combination with somatostatin analogue (SSA) therapy in adults inadequately controlled by SSA therapy.
News



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