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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 Commercial

Pfizer's Medivation Buyout: One-Off Deal Or Start Of A Biopharma Spending Spree?

More and larger M&A deals could boost public biopharmaceutical companies, so investors will watch closely to see if Pfizer's $14bn Medivation acquisition kicks off a widespread spending spree. Speculation about who'll be bought next is in full swing.

Commercial Business Strategies Companies

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

View From The Top Of IMI: Heading Up Life Sciences' Biggest Public-Private Partnership

Almost one year into his role as executive director of the Innovative Medicines Initiative (IMI), Pierre Meulien talks to Scrip about the successes and challenges of leading the world's biggest public-private partnership (PPP) in the life sciences and his plans for the second phase of the IMI vision.

Clinical Trials Neurology BioPharmaceutical
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Commercial Explore this Topic

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 Strategy

With Medivation, Pfizer Sees A Chance For More Combinations

Most of the $14bn value Pfizer agreed to pay to buy Medivation is tied to future growth of Xtandi, according to the company, but two pipeline assets and the potential to combine drugs could offer upside.

Clinical Development & Trials Deals Cancer

Latest From Commercial

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

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

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

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

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

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

Novartis Galvus India Case: Wockhardt Pulls Back?

Legal proceedings around Novartis' Galvus patent in India appear to have taken an interesting turn, with generic challenger Wockhardt indicating that it will retract its application for the revocation of the patent on the diabetes drug.

Commercial Patent Litigation India

Latest From 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

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

Portola Seeks Narrower Label For AndexXa Antidote After FDA Rebuff

Company had wanted accelerated approval for the antidote for all Factor Xa inhibitors, but will now focus the reversal agent on the two drugs commanding the largest markets – Bristol/Pfizer's Eliquis and J&J/Bayer's Xarelto.

Approvals Cardiovascular

Nixed Remicade Patent Clears Way For Pfizer/Celltrion Biosimilar Launch

A Massachusetts court's ruling invalidating a patent on Johnson & Johnson's Remicade (infliximab) appears to clear the way for Pfizer Inc. and Celltrion Inc. to finally launch their FDA-licensed biosimilar Inflectra (infliximab-dyyb). J&J, however, said it plans to appeal and any biosimilar launch would be considered "at risk."

Biosimilars Patent Litigation

Clinical / R&D Explore this Topic

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 Markets

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 BioPharmaceutical

Latest From Clinical R&D

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

PhIII 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

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

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

Cerulean Slashes Jobs After Phase II Kidney Cancer Failure

Cerulean will cut its staff by almost half to reprioritize its remaining cash as it recovers from a clinical trial failure for its lead drug candidate that shifts the program's immediate focus from kidney to ovarian cancer.

Clinical Trials Clinical R&D

PIPELINE WATCH: Two Approvals, Two Filings And One Withdrawal

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
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