Pfizer confirms £60bn bid interest in AstraZeneca

US-based drug maker Pfizer confirmed that it has contacted AstraZeneca seeking to renew discussions over a possible £60bn takeover.

The discussions are regarding developing a proposal by both companies that could be recommended to their shareholders. In January, UK-based AstraZeneca discontinued talks with Pfizer regarding its initial approach over the acquisition.

AstraZeneca has again declined to have been engaged in discussions with Pfizer, which has officially confirmed that it currently is considering options with respect to the UK firm.

Novartis to acquire GSK’s cancer drugs for $16bn

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Novartis reached a definitive agreement with GlaxoSmithKline (GSK) to acquire GSK’s oncology products, divest its vaccines business (excluding flu) to GSK, and create a new joint venture by combining their consumer divisions.

Under the terms of the definitive agreement, Novartis will pay $14.5bn to GSK and up to $1.5bn contingent on a development milestone to acquire its oncology products. Novartis would have opt-in rights to GSK’s current and future oncology research and development pipeline.

Novartis is expected further reinforce its oncology business and improve the growth profile of the combined portfolio with the acquisition of GSK’s oncology products. The addition of GSK products is expected to expand Novartis’ position in targeted therapies and small molecules.

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European Commission grants marketing approval for Teva’s DuoResp Spiromax


Teva Pharmaceutical obtained marketing authorisation approval from European Commission for its DuoResp Spiromax for treatment of patients with asthma and chronic obstructive pulmonary disease (COPD) when a combination inhaled corticosteroid and long-acting beta(2) adrenoceptor agonist is appropriate.

DuoResp Spiromax, a multi-dose dry-powder inhaler, contains a fixed-dose combination of budesonide and formoterol fumarate dehydrate. Budesonide is an inhaled corticosteroid indicated for the treatment of the underlying inflammation in asthma and COPD.

Formoterol fumarate dehydrate is a rapid-acting and long-lasting beta(2) agonist for the relief of bronchoconstriction in asthma and COPD. According to Teva, DuoResp Spiromax has been demonstrated to be therapeutically equivalent to the budesonide/formoterol combination.

Janssen’s type 2 diabetes drug Vokanamet gets European Commission approval in EU

Janssen-Cilag International (Janssen) received approval from the European Commission (EC) for use of Vokanamet in the European Union (EU) as a treatment for adults with type 2 diabetes mellitus to improve glycaemic control.

Vokanamet is a fixed-dose therapy that combines canagliflozin and immediate release metformin hydrochloride in a single tablet. In November 2013, canagliflozin as a single agent was approved as Invokana in the EU.

The approval follows a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommending the approval of canagliflozin and immediate release metformin hydrochloride fixed dose combination therapy in February.

New subcutaneous formulation of Roche’s arthritis drug RoACTEMRA wins European approval

The European Commission (EC) approved Roche’s subcutaneous formulation of RoACTEMRA (tocilizumab) to treat moderate to severe rheumatoid arthritis (RA) in patients who are either intolerant to or have failed to respond to other RA treatments.

The approval makes RoACTEMRA, the first anti IL-6 receptor biologic available as subcutaneous and intravenous (IV) formulations for both monotherapy and combination therapy with methotrexate (MTX).

EC approval was based on data secured from the Phase III SUMMACTA and BREVACTA trials. The SUMMACTA trial showed that efficacy and tolerability of subcutaneous RoACTEMRA was comparable with intravenous RoACTEMRA.

FDA approves Janssen’s Sylvant to treat multicentric Castleman’s disease


The US Food and Drug Administration approved Janssen Biotech’s Sylvant (siltuximab) to treat patients with multicentric Castleman’s disease (MCD) who are human immunodeficiency virus (HIV) negative and human herpesvirus-8 (HHV-8) negative.

The company said that the drug was not studied in patients with MCD who are HIV positive or HHV-8 positive because it did not bind to virally produced interleukin-6 (IL-6) in a non-clinical trial.

An IL-6 antagonist biologic therapy administered as an intravenous (IV) infusion once every three weeks, Sylvant is claimed to be the first approved treatment in the US for MCD, a rare blood disorder with high morbidity that involves lymphocytes being over-produced, which leads to enlarged lymph nodes.

Eli Lilly’s Cyramza becomes first FDA-approved gastric cancer drug


Eli Lilly obtained US Food and Drug Administration approval for its Cyramza (ramucirumab) as a single-agent treatment for patients with advanced or metastatic gastric cancer or gastroesophageal junction adenocarcinoma with disease progression on or after prior fluoropyrimidine or platinum-containing chemotherapy.

According to Lilly, approval of Cyramza (ramucirumab injection 10mg/ml solution) makes the drug the first FDA-approved treatment for patients with advanced gastric cancer after prior chemotherapy.

Approval of Cyramza is based on positive data from REGARD, a Phase III study of Cyramza and best supportive care (BSC) compared with placebo and BSC as gastric cancer, including gastroesophageal junction adenocarcinoma following progression after initial fluoropyrimidine- or platinum-containing chemotherapy.

Merck obtains FDA approval for grass pollen allergy drug


Merck obtained approval from the US Food and Drug Administration (FDA) for its Grastek (Timothy grass pollen allergen extract) sublingual tablet as immunotherapy for treatment of grass pollen-induced allergic rhinitis with or without conjunctivitis in children and adults.

Grastek has been developed for treatment of grass pollen-induced allergic rhinitis with or without conjunctivitis confirmed by positive skin test or in vitro testing for pollen-specific IgE antibodies for Timothy grass or cross-reactive grass pollens.

The recommended dose of Grastek is one tablet per day. Grastek is not indicated for the immediate relief of allergic symptoms and the drug can cause life-threatening allergic reactions such as anaphylaxis and severe laryngopharyngeal restriction.

BioAlliance Pharma and Topotarget join forces to create new orphan oncology company

BioAlliance Pharma and Topotarget announced a merger agreement with an aim to create an orphan oncology company with increased scale and a highly complementary pipeline of late-stage products targeting significant unmet medical needs.

Under the terms of the agreement, BioAlliance Pharma will be the continuing company and it will now apply for a dual listing of its shares at NASDAQ OMX Copenhagen. The new company is expected to benefit from operational efficiencies, combined pool of knowledge, and a diversified revenue stream.

Approved by the BioAlliance Pharma and Topotarget boards of directors, the merger is expected to result in a broadened shareholder base with increased market capitalisation and a strengthened value proposition for the US and European-based investors.

NICE recommends afatinib for treatment of lung cancer

The UK National Institute for Health and Care Excellence (NICE) issued its final health technology appraisal recommending afatinib as a first-line treatment option for patients with advanced or metastatic non-small cell lung cancer (NSCLC).

Afatinib is a targeted treatment for NSCLC known as an epidermal growth factor receptor (EGFR) TK inhibitor. Boehringer Ingelheim is currently developing afatinib (Giotrif) as the first oncology treatment for lung cancer patients in the UK.

NHS England has recommended that afatinib is reimbursed at day zero, rather than after the standard 90 day implementation period, which will allow patients with lung cancer to have immediate access to afatinib with a prescription.