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4Q Pharma Results Preview: J&J, Novartis, Bristol, Celgene, Biogen

Scrip offers some key points to watch for as Johnson & Johnson and Novartis kick off the big pharma full-year presentations Jan. 24, with Bristol-Myers Squibb, Celgene and Biogen Idec finishing off the first week of earnings season.

Sales & Earnings Companies Strategy

Pharma's Middlemen Get Fatter: PBM, Health Plan Rebates Near $58bn

Negotiated health plan and PBM rebates and fees have nearly doubled since 2013, PhRMA-commissioned report finds. After other rebates and discounts are added in, manufacturers retained 63% of total gross spending on branded drugs (based on list prices) –a decline, albeit less dramatic, from 2013.

Pricing Debate Commercial Market Access

Bristol Falls Further Behind Merck In NSCLC By Pulling Early Combo Filing

Bristol-Myers Squibb's decision not to seek accelerated FDA approval for its Opdivo/Yervoy combo in early lung cancer shocked investors - but analysts still expect a filing to come, albeit later than first thought.

Cancer Approvals Business Strategies

US Drug Spending: Where Does All The Money Go?

PhRMA has released new data on where gross and net drug expenditure ends up along the pharmaceutical supply chain, which will support its position the debate over US drug pricing.

Pricing Debate Market Access Commercial
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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 People

Novartis’s Evolving R&D: An Interview With CMO Narasimhan At J.P. Morgan

Novartis is under pressure to deliver new drugs in areas like oncology, cardiovascular disease and dermatology, where it is making significant investments. Chief Medical Officer Vasant Narasimhan talked about the company’s strategy in these areas and others, the company’s recent R&D reorganization and business development in an interview during the J.P. Morgan Healthcare Conference.

Commercial Companies Business Strategies

Latest From Commercial

EpiPen Competitor Auvi-Q Relauching With Ultimate Copay: $0

Under kaléo's new access program, patients with insurance will have no co-pay and uninsured people with less than $100,000 income will get the product for free.

Commercial Business Strategies

Mallinckrodt's FTC Settlement Seems A Blip For Acthar Blockbuster

Company anticipates steady sales of its blockbuster treatment for infantile spasms and other severe conditions for many years, despite agreement to out-license a potential competitor as part of settlement with US trade commission. Settlement resolving investigation into earlier Questcor acquisition also includes $100m fine.

Commercial Companies

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

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

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

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

Policy & Regulation Explore this Topic

2017 Preview: Fresh Concerns And New Hopes In China

If 2016's Year of the Monkey was a period of ups and downs in China, filled with a series of rapid changes in regulations and plans for overseas expansion by domestic pharma companies, 2017's Year of the Rooster is likely to be even more uncertain, industry insiders say.

Policy & Regulation China Policy

Patent Settlement Offers Some Salve For Bristol’s PD-1 Wounds

Bristol-Myers Squibb has taken a beating over setbacks for its Opdivo and its immuno-oncology portfolio, but a settlement reached with Merck over Keytruda’s patent infringement is a momentary victory for the PD-1 pioneer.

Intellectual Property Legal Issues ImmunoOncology

Mallinckrodt's FTC Settlement Seems A Blip For Acthar Blockbuster

Company anticipates steady sales of its blockbuster treatment for infantile spasms and other severe conditions for many years, despite agreement to out-license a potential competitor as part of settlement with US trade commission. Settlement resolving investigation into earlier Questcor acquisition also includes $100m fine.

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

Research & Development Explore this Topic

Pipeline Watch: Phase III Starts With Durvalumab, Atezolimumab And Eravacycline

Pipeline Watch has been updated to bring greater depth and detail to a potential therapeutic product’s progress through the R&D pipeline. The table brings you a snapshot of selected late-stage clinical trial events in the pharma and biotech industries.

Pipeline Watch Approvals Research & Development

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 Infectious Diseases

Latest From Research & Development

UCB’s Cimzia Set To Make A Late Entrance At Psoriasis Party

UCB has reported positive data from the final Phase III trial of its anti-TNF product Cimzia in plaque psoriasis, paving the way for approval applications later this year, but the product will have to elbow its way into a competitive market already under the shadow of a biosimilar threat.

Clinical Trials Companies

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 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

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

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
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