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Investors Ignore Trump On Pricing

When Donald Trump said on Jan. 11 that the drug companies were “getting away with murder” on pricing, some took his words seriously. But his shapeless message had no meaning for the markets. Investors glanced up from their screens momentarily but they don’t believe he will do anything about drug pricing.

Pricing Debate Government Payers BioPharmaceutical

Pharma’s Pricing Debate Splinters As US Political Confrontation Looms

Drug makers are embracing different strategies on the pricing issue as the industry marches closer to a confrontation with President-Elect Trump over the cost of medicines.

Pricing Debate Generic Drugs Government Payers

Lilly Pays Nearly $1bn To Regain Migraine Candidate It Once Sold For $1m

In acquiring biotech CoLucid and its Phase III acute migraine candidate lasmiditan for $960m, Lilly gets back an asset it discovered and out-licensed more than a decade ago. The pharma hopes to pair the 5-HT1F agonist with galcanezumab to create a two-drug migraine franchise.

Deals M & A Neurology

Europe's Pharma Tries To 'Keep Calm And Carry On' Amid Storm Strikes

Pharma leaders in the UK and Europe have had a stormy start to the week, as the UK government revealed its aim to leave the single market and the OECD issued a loud call for drug makers to restrain their prices.

Europe Brexit BioPharmaceutical
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Biogen Pays $1.25bn For Peace Of Mind Over Tecfidera, But Legal Wrangling Continues

Biogen's new CEO Michel Vounatsos has begun his tenure by taking out a $1.25bn "insurance policy" on MS drug Tecfidera by licensing Forward Pharma's patent portfolio, but the cost of the deal could spiral if the Danish firm wins a series of ongoing patent disputes with Biogen concerning Tecfidera and Forward Pharma's MS drug candidate FP187.

Commercial Legal Issues Neurology

Cipla 2.0: ‘Disproportionate’ US Growth, Getting The Profit Curve Right

Cipla is planning an ambitious growth trajectory, aiming to propel its US business “towards a $1bn generic enterprise” and develop a strong specialty franchise focused on its traditional stronghold, the respiratory segment, and the CNS space.

Commercial Strategy United States

Latest From Commercial

Genital Herpes: New Therapeutic Approaches Advance

New vaccines and a compound with new mechanism of action that are in early clinical trials suggest the poorly served antiherpes market could be rejuvenated in the next few years.

Market Intelligence Commercial

CEPI Global Vaccines Launch May Augur Creation Of Credible Davos Deal

If in five years' time the newly launched CEPI coalition successfully produces DNA and RNA-based vaccines for use against future epidemics, then the high-profile Davos forum will really have something to crow about.

Commercial Companies

GSK Management Shake Up Ahead Of New CEO Sees Hussain Out, AZ's Miels In

"Succession processes are challenging for everyone involved and, unfortunately, it is rare that all of those involved stay with the company," stated GSK's out-going CEO Andrew Witty, as Abbas Hussain decides to leave the company having lost out on the top job, which went to Emma Walmsley. His successor will be AstraZeneca's Luke Miels.

Companies Commercial

Takeda Targets Severe Epilepsies In Ovid Alliance

Takeda is continuing apace with smaller targeted alliances despite its big Ariad acquisition, this time linking with a private US venture for the global development of a novel drug for serious pediatric epilepsies, in a move that aligns with the Japanese firm's pursuit of R&D externalization.

Commercial Deals

Daiichi Seeks To Stall Singh Asset Sales In Ranbaxy Compensation Battle

Daiichi Sankyo has chalked up a procedural win in its ongoing court battle for compensation from Indian tycoons Malvinder and Shivinder Singh over the Japanese company’s ill-fated acquisition of Indian generic giant Ranbaxy.

Commercial Legal Issues

AstraZeneca Updates MYSTIC Plan In Bid To Challenge Merck In NSCLC

With tensions rising in the first-line NSCLC space, AstraZeneca's update on the analysis plan of its Phase III MYSTIC trial has analysts reassessing the firm’s chances against stiff competition.

ImmunoOncology Cancer

Policy & Regulation Explore this Topic

Shionogi Eyes ’17 US Cefiderocol Filing After New Results

Shionogi's novel antibiotic cefiderocol has met its primary endpoint in a pivotal clinical trial, clearing the way for a US approval filing this year for what will be a strategically important product for the Japanese company.

Research & Development Clinical Trials Infectious Diseases

Pharma's Latest Davos Pledge: Sincere, Or Just Keeping Up Appearances?

Many hope the "dialogue of the deaf" between pharma and other healthcare stakeholders can be truly bridged by the industry's latest Davos declaration to collaborate in targeting chronic diseases of the poor.

Analysis Commercial Companies

2017 Not Looking As Bright As It Should Be For Turkish Pharma

The pharmaceutical industry in Turkey has started 2017 cautiously despite a basically dynamic market and increasing demand for healthcare, with continued pricing and cost pressures, and political and economic instability, likely to dampen new investments.

Turkey Policy & Regulation

On The Sunny Side Of Trump Street: Biopharma Ready For Tax Reform

Industry experts expressed optimism for tax reform at the Biotech Showcase and J.P. Morgan Healthcare Conference, though there is concern about the future of the federal Small Business Innovation Research program.

Policy US Election 2016

AstraZeneca, Eli Lilly and Cancer Dominate 2016 EU New Drug Approvals

2016 saw 30 new active substances approved in the EU, in a total of 29 different products, of which 10 were for cancer indications. Two companies shared the honors for productivity: AstraZeneca and Lilly each saw three new active substances approved by the European Commission during the year.

Europe Approvals

Trump Throws Pharma A Curve Ball On The Third Day Of J.P. Morgan

Pharmaceutical manufacturers have been waiting for Trump’s ax to fall – and it finally did, on the final full day of the industry’s biggest business meeting of the year.

Pricing Debate Market Access

Game Changer: Merck's Stealth Keytruda-Chemo Filing Stirs NSCLC Market Dynamics

Merck & Co. has stealthily filed its highly anticipated Keytruda plus chemotherapy combination for first-line treatment of non-small cell lung cancer on the back of Phase II data, months earlier than expected and before the completion of a Phase III study.

ImmunoOncology Research and Development Strategies

J.P. Morgan Notebook Day 1: PCSK9 Face-Off, Teva’s Slowed Growth, Merck’s Keytruda Wins, Lilly’s CDK4/6 Hopes And More

Daily round-up of news and notes from the 2017 J.P. Morgan Healthcare conference in San Francisco. Regeneron CEO rebuffs Amgen’s patent battle strategy; Teva CEO apologizes for reduced financial guidance; Merck looks for more Keytruda wins, combos; Lilly awaits potentially differentiating Phase III CDK4/6 data; Alkermes readies ALKS 5461 depression submission; Biden discusses cancer moonshot; FDA’s real world evidence views; and UniQure turns a corner.

Commercial Companies

Research & Development Explore this Topic

Prostate Cancer Vaccines: What’s In The Pipeline?

The sector still attracts the attention of clinical investigators and the pharmaceutical industry, despite disappointing results from another clinical-stage candidate.

Commercial Market Intelligence Cancer

Alcobra Ends Development Of MDX For Adult ADHD, Ponders Strategic Direction

Failing to meet the primary endpoint in its second Phase III study in adult ADHD, the Israeli firm confirms there is no path forward in that indication. Developing MDX for Fragile X syndrome and business development options are under consideration.

Drug Safety Neurology Clinical Trials

Latest From Research & Development

CEPI Global Vaccines Launch May Augur Creation Of Credible Davos Deal

If in five years' time the newly launched CEPI coalition successfully produces DNA and RNA-based vaccines for use against future epidemics, then the high-profile Davos forum will really have something to crow about.

Commercial Companies

AstraZeneca Updates MYSTIC Plan In Bid To Challenge Merck In NSCLC

With tensions rising in the first-line NSCLC space, AstraZeneca's update on the analysis plan of its Phase III MYSTIC trial has analysts reassessing the firm’s chances against stiff competition.

ImmunoOncology Cancer

VENUS II Paves Way For Allergan's Ulipristal NDA In Uterine Fibroids

Ulipristal, which is marketed as Ella in the US for emergency contraception, meets all primary and secondary endpoints in the pivotal VENUS II study, supporting an NDA for uterine fibroids in the second half of 2017.

Clinical Trials Gynecology & Urology

Mixed Data Cloud Future Of Sunovion's ADHD Drug

Sunovion's ADHD drug, dasotraline, has missed its primary endpoint in a Phase III study in adult patients but has reported mixed results in children, prompting the company to continue pursuing its 2017 plans for an FDA filing in both age groups. But data for the non-stimulant ADHD therapy suggest it will be tricky to overthrow market stalwarts.

Clinical Trials Research & Development

Tech Transfer Roundup: J&J Innovation’s Agnostic Approach To Academic Collaboration

J&J’s Robert Urban explains how his organization’s efforts lead to partnerships with academia across a broad range of areas, including pharmaceuticals, medical devices and consumer products. Also, transactions occurring between Nov. 21 and Dec. 21, including the expansion and solidification of Editas Medicine’s IP estate in CRISPR technology.

Deals StartUps and SMEs

BioMarin Set Sights On Pivotal Gene Therapy Hemophilia Study

Promising early data for BioMarin’s investigational gene therapy for hemophilia, BMN 270, could suggest it could “normalize life” for patients.

Clinical Trials Research & Development
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