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Novartis Dismisses Turkish Bribery Claims

Whistleblower claims that Novartis had benefited in Turkey from business advantages brokered by a local consulting firm appear to have come to naught, with the Swiss company claiming that as far as it is concerned the matter is now closed.

Turkey Policy & Regulation BioPharmaceutical

Indian Clinical Research Sector: Hope And Despair Amid Shutdowns

India's clinical research segment has had a rough time of late. Uncertainties, evolving regulations and compliance deviations have hurt the sector that is now scarred with firms downing the shutter, mistrust and constant speculation. Scrip spoke to a number of CROs who appear to have weathered the storm, but it seems the industry may not be out of the woods just yet.

Clinical R&D Clinical Trials Policy & Regulation

Mylan Could Get Out Of EpiPen Price Backlash With A Little Contrition, Analyst Says

Mylan CEO Heather Bresch may have done her company little favors by arguing it couldn't reduce EpiPen's price, with one analyst telling the firm it needs to get a little contrition and acknowledge its decision to raise the medicine's cost.

Companies Policy & Regulation Pricing Strategies

GSK, J&J And Roche Speak Up On Women's Equality Day

On Women's Equality Day Scrip spoke to big pharmas, including GlaxoSmithKline PLC, Roche and Johnson & Johnson, about gender equality issues that need highlighting across the life science industry and what their businesses are doing to promote equal opportunities and fair pay.

Business Strategies Market Intelligence Companies
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Commercial Explore this Topic

Oncology Focused Investment Comes Into Its Own

UBS closed its $471m Oncology Impact Fund, a specialist investment vehicle for early stage oncology, in April this year. But it was by no means the first commercial investment vehicle to focus solely on oncology. Nextech Invest raised its fourth oncology fund in July this year.

Commercial Cancer BioPharmaceutical

Sanofi Could Pursue Other Oncology M&A Targets After Medivation Loss

Losing Medivation could end up being a winning proposition for the French pharma if it can boost its cancer franchise another way, like by acquiring its partner in multiple collaborations Regeneron or making a less expensive takeout, such as Incyte or Ariad.

Commercial Cancer Deals

Latest From Commercial

Denali Builds Neurodegeneration Pipeline Through Discovery, Collaborations And Lots Of Cash

The amount of venture capital that Denali Therapeutics Inc. has raised and the number of collaborations it's negotiated in less than two years is pretty staggering for a startup biopharmaceutical company, not to mention a startup focused on the central nervous system and neurodegeneration.

Commercial Deals

Amgen Gets Parsabiv CRL, Gives No Clues As To Why

FDA issued a complete response letter for the Sensipar follow-on, and Amgen declined to provide any details about the reason why or timeline for resubmission.

BioPharmaceutical Commercial

SPARC Pins Hope On Halol Plant For Elepsia FDA Nod But Has Plan B

Sun Pharma’s research arm SPARC says it’s still convinced its Indian parent’s troubled Halol plant offers the shortest route to US regulatory approval for its epilepsy drug Elepsia and its glaucoma medicine Xelpros. US FDA clearances of both drugs have been stalled by manufacturing lapses at Sun Pharma’s factory. But SPARC says it has a manufacturing 'plan B' if necessary.

Commercial Manufacturing

AstraZeneca Sells Small-Molecule Antibiotics To Pfizer But Still Investing In R&D

AstraZeneca is selling its late-stage small molecule antibiotics business to Pfizer in a deal that could reach more than $1.5bn, but the company – one of just a few big pharmas working in antibiotics R&D – says it will continue to study novel antibiotics via its MedImmune biologics division.

Deals Companies

EpiPen's Swollen Price May Trigger Patient Assistance Program Probes

Mylan's $600 price tag for its emergency anaphylaxis treatment EpiPen (epinephrine) could spur more than probes into the company's pricing practices. It could turn into a wider investigation into industry's use of patient assistance programs.

Pricing Strategies Policy & Regulation

Hikma Hit By Approval Delays, But Advair Diskus Generic Expected Next Year

Jordan's Hikma claims to be a more balanced generics company after the Roxane acquisition, and expects 2017 approval of an Advair Diskus generic, but delays in US generic approvals held back profits in the 2016 first half.

Commercial Approvals

Policy & Regulation Explore this Topic

Irish Drug Prices Face Annual Cuts Under New Four-Year Deal

The new Irish drug pricing deal, aimed at achieving savings of €785m over four years, provides for regular price cuts and rebates, price reductions for biologicals when biosimilar versions are marketed, and a new mechanism for dealing with high-cost medicines.

Pricing & Regulation Ireland Government Payors

Truvada Sales To Rise On EU Okay In HIV Prevention; UK Use Uncertain

The EU’s approval of Gilead’s Truvada for pre-exposure prophylaxis makes it the first medicine licensed in Europe to reduce the risk of HIV transmission through sexual intercourse and puts pressure on Britain’s reluctant, cash-strapped National Health Service to provide public funding for the drug’s preventative use.

Europe United Kingdom Combination Products

Latest From Policy & Regulation

EpiPen's Swollen Price May Trigger Patient Assistance Program Probes

Mylan's $600 price tag for its emergency anaphylaxis treatment EpiPen (epinephrine) could spur more than probes into the company's pricing practices. It could turn into a wider investigation into industry's use of patient assistance programs.

Pricing Strategies Policy & Regulation

Pfizer/Celltrion Prep For October Inflectra Launch

With Celltrion shipping the first batch of its biosimilar Inflectra (infliximab-dyyb) and a stipulation agreement with Johnson & Johnson, Pfizer is set to launch the product on Oct. 3 – six months after it was approved in the US.

BioPharmaceutical Biosimilars

Pharmaceutical R&D In Turkey: Important Steps Forward But A Long Way To Go

After decades of little pharmaceutical R&D investment in Turkey, there has been a significant 138% upswing in recent years. Government incentives are playing their part in increasing the country's attractiveness, but significant problems remain for the industry.

Turkey Commercial

NICE Reassessing Old CDF Drugs On Value-For-Money Basis – Some Fail

NICE has begun the new HTA appraisal process for Britain’s remodeled Cancer Drugs Fund and has so far provisionally rejected three of the 35 drugs contained in the old CDF on cost-effectiveness grounds; two others got a thumbs up after their manufacturers offered further price cuts.

Cost Effectiveness Health Technology Assessment

Innovators Employ Labyrinthine Defenses To Fend Off Biosimilars

Innovators are using increasingly complicated tactics in the high-stakes game of keeping biosimilars at bay to ensure their brand-name medicines can keep hauling in the cash for as long as possible.

Policy & Regulation Patent Litigation

What Would It Take To Attract Global Pharmas To Korea?

What do successful biopharma countries have in common? At a recent biopharma industry seminar in Incheon, South Korea, delegates stressed the importance of creating strong bioclusters if the country is to transform itself into a biopharma-focused nation.

Policy & Regulation South Korea

Clinical / R&D Explore this Topic

Interview: GSK India's Playbook For Vaccines Dominance

Deft pricing and effective physician engagement appear to have helped shape GSK's sustained dominance in the Indian self-pay vaccines market. GSK Pharmaceuticals India managing director, Annaswamy Vaidheesh, takes Scrip through some of the strategies at play including the sharp recalibration in the price of Synflorix and how the British multinational is harnessing digital technology to stay "close" to its customers.

Commercial Strategy India

Phase III Endpoint Hit For Novartis's Gilenya Follow-On In Progressive MS

Novartis AG's Gilenya follow-on drug, BAF312 (siponimod), has met its primary endpoint in the Phase III EXPAND trial, giving the drug a positive outlook for approval as a treatment for underserved secondary progressive multiple sclerosis (SPMS) patients.

Clinical R&D Clinical Trials Neurology

Latest From Clinical R&D

CardioCell To Pursue Large-Scale Chronic Heart Failure Trial For IV Stem Cell Therapy

CardioCell has presented data from the first clinical trial to demonstrate the safety and viability of intravenous (IV) ischemia-tolerant mesenchymal stem cells in chronic heart failure patients – dispelling the theory that only large amounts of stem cells delivered directly to the myocardium would achieve improvements in patient outcomes.

Cardiovascular Clinical Trials

PIPELINE WATCH: Five Approvals, Eight Filings And One Launch

This week's Pipeline Watch, a snapshot of all the late-stage R&D and regulatory events in the pharma and biotech industries, is now available to view.

Clinical R&D Pipeline Watch

Amgen Gets Parsabiv CRL, Gives No Clues As To Why

FDA issued a complete response letter for the Sensipar follow-on, and Amgen declined to provide any details about the reason why or timeline for resubmission.

BioPharmaceutical Commercial

INTERVIEW: Oscotec Lays Out Global Ambitions For RA, Cancer Drugs

Executives from the South Korean bioventure firm Oscotec talk to Scrip about the significance of the recent license agreement for a third-generation EGFR inhibitor by partner Yuhan, and extolled the company’s other core pipeline products, which include novel candidates for rheumatoid arthritis and cancer.

Clinical R&D Commercial

Lundbeck's Alzheimer's Strategy Targets Symptoms And Disease Modification

The private company may be behind the leaders, but with a long-term plan and a strategy of coming in with complementary therapies like the 5-HT6 receptor antagonist idalopirdine and the dopamine antagonist Rexulti (brexpiprazole), it could be a stable player in Alzheimer's.

Strategy Clinical Development & Trials

Cytokinetics Seeks ALS Success By Focusing On Lung Function

Despite an earlier Phase II failure on broader ALS endpoint, biotech thinks it can demonstrate efficacy in slowing lung-function decline in ALS patients.

Neurology Clinical Trials
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