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Therapy Areas

Cardiovascular

Set Alert for Cardiovascular

Latest From Cardiovascular

Q4 Preview: How Will Bayer Survive Patent Cliff?

Ahead of the German major's fourth-quarter earnings call Feb. 27, analysts at Bernstein have been weighing up Bayer's chances of surviving the patent expiries on Xarelto and Eylea.

Sales & Earnings Intellectual Property

Sanofi/Regeneron Cut Praluent List Price As PBMs Look To Maintain Rebate Status Quo

The move follows a similar price cut for Amgen's competing PCSK9 inhibitor Repatha and comes as PBMs, including UnitedHealth Group's OptumRx, are looking for ways to maintain the drug rebate status quo.

Commercial Pricing Strategies

Biotech Showcase 2019: Rexgenero Advances CLI-Focused Regenerative Medicine Into Phase III

Joe Dupere, CEO at Rexgenero, reveals to Mike Ward during Biotech Showcase 2019 the four-year-old UK biotech’s plans. 

Clinical Trials Cardiovascular

Clinical Trials In Review: Big Hits And Misses In 2018

Scrip looks back at the studies released in 2018 and highlights trials that had a large impact, for better or worse.

Clinical Trials Approvals

Can Vivus Get Away Without Outcomes Study Of Obesity Drug Qsymia?

Fixed-dose combination of phentermine and topiramate is FDA-approved for chronic, long-term use, but the average duration in the real world is only about 2.1 months, which is reassuring for Qsymia’s cardiovascular safety, according to a new retrospective claims study.

Clinical Trials Cardiovascular

MyoKardia Frames End Of Sanofi Partnership As A Bet On Itself

Biotech regains full rights to a pair of targeted therapies for heart diseases, but will bear full development costs. MyoKardia says the agreement with Sanofi ended due to differences over commercial rights, not concerns about trial data.

Commercial Cardiovascular
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CNS

Set Alert for CNS

Latest From Neurology

Tanezumab Dances Through Back Pain Studies With “Acceptable” Safety Answers

In its latest TANGO trial for chronic lower back pain, Eli Lilly and Pfizer’s tanezumab has shown efficacy at 10 mg, but its 5 mg dose missed the statistically significant mark. Vitally, analysts are encouraged by safety data.

Clinical Trials Research & Development

Facing Up To A Patent Cliff: Indivior Plans For Loss of Suboxone Film Exclusivity

With sales of its largest-selling product under threat from generic competition, a couple of new products and cost cuts are put forward to reinvigorate Indivior, a leader in addiction therapies.

   

Neurology Business Strategies

Another World-First As Japan OKs Spinal Injury Cell Therapy Trial

In another globally pioneering move, Japan approves a trial with its flagship iPS cell technology in spinal cord injury, following a controversial earlier marketing approval in the same indication.

Japan Regenerative Medicine

Shire Solid But Hemophilia Challenges Looming?

Shire puts in solid results in last full year before Takeda acquisition, with 4% sales growth and strong cash flow, but there was some weakness in hematology stemming from lower ex-US prices and rising competition.

Business Strategies Commercial

Pressure Builds On Lundbeck After Rexulti Fails In Bipolar I Manic Episodes

Rexulti failed in two Phase III trials to statistically separate from placebo in bipolar I manic episodes.

Business Strategies Commercial

Janssen’s Esketamine Gets US FDA Panel Endorsement, But With Pricing, Access And Diversion Concerns

Committee overwhelmingly supports approval for treatment-resistant depression but warns that pricing and combination therapy indication could hinder patient access. Esketamine’s risks of sedation and dissociative effects, and its abuse potential, will necessitate a strict risk management strategy.

Advisory Committees Drug Review
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Immunology

Set Alert for Immunology

Latest From Immune Disorders

Mortality Signal For Pfizer's Xeljanz In Rheumatoid Arthritis Puts A Damper On JAK Class

Analyst speculates that risk of pulmonary embolism for a higher unapproved of Xeljanz in arthritis could trigger a label change for the same regimen in the drug's ulcerative colitis indication.

FDA Immune Disorders

Shire Solid But Hemophilia Challenges Looming?

Shire puts in solid results in last full year before Takeda acquisition, with 4% sales growth and strong cash flow, but there was some weakness in hematology stemming from lower ex-US prices and rising competition.

Business Strategies Commercial

What GSK's Immunology Chief Did Next

Paul Peter Tak recently defected from big pharma to East Coast venture firm Flagship Pioneering. He described the appeal of entrepreneurship in the biotech world and the value of taking the road less traveled when it comes to biomedical R&D.

Leadership Research and Development Strategies

Carry On Cosentyx As Novartis Lines Up More Blockbusters

The Swiss giant has posted a strong set of results with the company highly confident that its flagship immune drug can keep the competition at bay.

Sales & Earnings Immune Disorders

Shaken MorphoSys ‘Assessing Options’ After Losing US Darzalex Patent Ruling

But German Biotech says court summary judgement will have no bearing on MorphoSys's own CD38 antibody MOR202.

Legal Issues Platform Technologies

AbbVie’s Business Development, Cancer Plans Not Put Off By Stemcentrx Disappointments

At J.P. Morgan, AbbVie said the clinical struggles of Rova-T won’t alter its deal-making plans and leave it with plenty of solid tumor possibilities. The pharma took a $4bn write-off of the Stemcentrx deal on Jan. 4.

Business Strategies Commercial
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Infectious

Set Alert for Infectious Diseases

Latest From Infectious Diseases

Evotec Extends Anti-Infectives Footprint With Helmholtz Collaboration

Building on a leading position in anti-infectives research, Evotec aims to develop a new class of antibacterials based on cystobactamids, which are found in slime bacteria and have potent activity against serious bacterial pathogens.

 

Infectious Diseases Research and Development Strategies

Money Too Tight To Mention At Motif After Iclaprim 'No' From FDA

Hit with a complete response letter from the US FDA for its antibiotic to treat ABSSSI, Motif needs to raise funds and fast to stay afloat and prepare a meeting package to discuss the next steps for iclaprim with the agency.

Financing Infectious Diseases

Commercial, Reimbursement Hurdles Need To Be Addressed By Antimicrobial Resistance Efforts

Melinta describes difficulties launching its new antibiotics at BIO CEO & Investor Conference; companies and other stakeholders urge Congress to enact package of incentives to reinvigorate antibiotic pipeline.

Infectious Diseases Commercial

Affinivax’s MAPS Vaccine Technology Reaches Clinic In Under Five Years

Funded entirely by grants and partnerships to date, Affinivax’s pneumococcal vaccine candidate has begun a Phase I/II study less than five year’s after the biotech’s founding. Firm thinks its technology may eventually apply to immuno-oncology as well.

Vaccines Clinical Trials

Lyme Disease Vaccine Pushes Valneva To US Listing

Thomas Lingelbach talks to Scrip about Valneva’s plans for a US IPO to fund Phase III studies of its lead Lyme disease vaccine.

Infectious Diseases Vaccines

Merck's Keytruda Lead Widens Over Competing Checkpoint Inhibitors

CEO Ken Frazier had to argue the case that Merck has a diversified portfolio in yet another strong quarter for the PD-1 inhibitor Keytruda.

Sales & Earnings ImmunoOncology
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Metabolic

Set Alert for Metabolic

Latest From Metabolic Disorders

Old Dog, New Tricks: Label Expansions Invigorate Diabetic Nephropathy Market

With four new entrants readying to be prescribed in the next four years, the market for diabetic nephropathy is looking more buoyant than ever. However, competition from GLP-1 agonists and eventually from generics could put a dampener on proceedings.

 

Metabolic Disorders Renal

Galapagos Targets Liver Fibrosis With Evotec Deal

Belgium’s Galapagos adds another potential fibrosis drug to its growing pipeline of compounds in a therapeutic area that is also attracting attention from a number of other companies.

 

Clinical Trials Deals

Novo Nordisk Using Priority Review Voucher To Propel Oral Semaglutide To Market

Danish diabetes fighter will file oral semaglutide with FDA within months using a priority review voucher to reduce the time for expected approval to six months.

Approvals Business Strategies

Anticancers, Orphans & The First CAR-Ts: New EU Drug Approvals In 2018

New approvals in the EU were again dominated by oncology drugs in 2018, although medicines for infectious diseases were a close second. The number of orphan drugs more than doubled over the previous year, to 17. There were also some star arrivals in multiple sclerosis, genetic disorders, metabolism and migraine.

Approvals Europe

Standing On The Shoulders Of Giants: Could Arecor Enter The Race To Revolutionize Diabetes?

A small Cambridge, UK-based company, which is more at home partnering with the pharma industry than competing with it, is readying its run into the diabetes space with its ultra-rapid acting insulin. Scrip talked to its CEO to about the company’s biggest year yet.

Strategy Clinical Trials

Scrip Asks... What Will 2019 Hold For Biopharma? Part 1: Therapeutic Advances

Scrip journalists asked industry executives, consultants and analysts what they believe the big themes, trends and events will be in 2019. Here's what they told us about advances in therapeutic technologies and areas of clinical innovation.

Innovation Market Intelligence
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Oncology

Set Alert for Oncology

Latest From Cancer

Nektar/Bristol Show Promise With Double IO Combo, But Numbers Are Small

Updated data from PIVOT-02 at the ASCO GU meeting suggest a path for accelerated approval of the NKTR-214/Opdivo combination as first-line treatment of patients with PD-L1-negative urothelial cancers.

Clinical Trials Research & Development

Bayer Bags Full Vitrakvi Rights As Lilly Signs Off Loxo Buy

When buying Loxo, Lilly highlighted the importance of LOXO-292, a first-in-class oral RET inhibitor, rather than the already-approved Vitrakvi, perhaps knowing that partner Bayer was going to be exercising an option to take full control of the TRK inhibitor.

Deals Personalized Medicine

Bruised Roche Wins Another UK Perjeta Round With Price Cut

In the latest round of what appears to have been a bruising set of price negotiations for Roche, the UK’s cost effectiveness agency NICE has recommended Perjeta in another breast cancer setting.

United Kingdom Cancer

Bayer Sees Room For Third-To-Market Darolutamide In Prostate Cancer

ASCO GU: Darolutamide is important for the company's oncology portfolio, but does it have enough to compete against J&J's Erleada and Pfizer/Astellas' Xtandi?

Cancer Gynecology & Urology

Tagrisso Climbs Close To Top Of AstraZeneca Sales Tree

The drug major has presented a set of financials that have comfortably surpassed analyst forecasts and show that its new oncology therapies now make up around 30% of group sales and are growing strongly.

Sales & Earnings Cancer

US Rights Deal Will Make Proleukin Clinigen's Biggest Product

Clinigen's planned purchase of US rights to Proleukin will give it global ownership of the IL-2 drug.

Business Strategies Deals
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Respiratory

Set Alert for Respiratory

Latest From Respiratory

Mylan Launches Advair Generic Wixela At 70% Discount To GSK's Branded Drug List Price

Two weeks after the product's approval, Mylan finally has launched Wixela and revealed a big price cut for the asthma and COPD medicine over the brand; the actual savings for patients remains dependent on payer negotiations and other factors.

Generic Drugs Pricing Strategies

What Advair? GSK Plays Up Budding Oncology Pipeline In Q4 Call

GSK said its oncology pipeline has doubled in size since July to include 16 assets in the clinic and highlighted the newly in-licensed bifunctional immunotherapy M7824.

Sales & Earnings Cancer

Revamped Redx’s New CEO Says Porcupine Inhibitor Trials 'Now On Track'

After regulatory talks, revamped Redx gets green light to resume clinical study of RXC004 in patients with advanced solid tumors, while sister porcupine inhibitor RXC006 is set to enter IPF trials in 2020, the biotech's CEO tells Scrip.

Clinical Trials Cancer

Verona Investors Gasp As Lead Asset Misses Main Endpoint In COPD Trial

Verona’s shares sank after a brief three-day Phase II trial using lead asset RPL554 in patients already maximally bronchodilated on both a LAMA and LABA missed the primary endpoint.

Clinical Trials Respiratory

Imutex's Universal Flu Vaccine Inches Forward On New Data

The Imutex joint venture between hVIVO and the SEEK Group updates promise of its universal flu vaccine candidate after additional data from a Phase IIb study showed a statistically significant effect on its primary endpoint.

 

Clinical Trials Infectious Diseases

Vectura Breathes Easy As It Enters Eventful 2019

With a steady stream of royalties coming in from Flutiform and Ultibro and a decent pipeline of innovative respiratory drugs and generics, Vectura has presented a promising update for the year ahead.

Sales & Earnings Respiratory
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