Scrip is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

Therapy Areas

Cardiovascular

Set Alert for Cardiovascular

Latest From Cardiovascular

Novo Nordisk Enters Its First Strategic RNAi Pact

Novo Nordisk’s head of global drug discovery tells Scrip he hopes the strategic collaboration with Dicerna Pharmaceuticals will generate clinical candidates within three years.

Commercial Companies

Amarin Heads Into Vascepa Expansion Labeling Talks After Positive US FDA Panel Review

Focus of negotiations with agency will be on breadth of population encompassed by a cardiovascular risk reduction indication; most advisory committee members favored a broad claim for secondary and primary prevention reflecting the REDUCE-IT trial population, but some strongly opposed an indication that includes patients without established CV disease.

Advisory Committees Drug Review

Five Trials To Look Out For At The AHA Meeting

Philadelphia is due to host the American Heart Association (AHA) meeting for the first time from 16-18 November, with the conference taking place in its condensed three-day format for just the second time. Scrip takes a look at the expected highlights.

Clinical Trials Companies

Amarin's Vascepa Momentum Builds Ahead Of Next Week's FDA AdComm

Sales of the triglyceride-lowering medicine soared to $112.4m in the third quarter even before a label expansion that depends on the outcome of a vital US FDA advisory committee meeting on 14 November.

Cardiovascular Sales & Earnings

Roundup Lawsuits Overshadow Pharma Growth At Bayer

Pharmaceutical sales hit €4.35bn helped by a strong showing in China but as the number of glyphosate plaintiffs in the US jumps to 42,700, the German group's priority is sorting out Monsanto.
Legal Issues Sales & Earnings

Pfizer Vyndaqel Launch Surprises With An Early Burst Out Of The Gate

The drug outperformed investor expectations, generating $79m in the US in its first full quarter on the market, after Pfizer had set low expectations for the initial launch.

Launches Rare Diseases
See All

CNS

Set Alert for CNS

Latest From Neurology

Karuna Upbeat On New Antipsychotic Mechanism Data

Karuna Therapeutics’ top-line Phase II data for a combination of a centrally acting muscarinic agonist, xanomeline, and a peripherally acting muscarinic antagonist, trospium, were greeted with enthusiasm by investors and the Boston, MA-based biotech.

 

Neurology Clinical Trials

Alkermes Invests In Novel CNS Targets With Rodin Acquisition

Rodin is developing HDAC CoREST complex inhibitors for neurological conditions, with a lead candidate having completed Phase I testing. Alkermes will pay $100m upfront.
Deals Neurology

ResTORbio Pins Hopes On Parkinson’s After Failed CSRI Study

Company terminates studies of its TORC1 blocker after it fails to prevent respiratory illness in elderly patients with clinically symptomatic respiratory illness (CSRI). ResTORbio is hoping the same drug will be effective in Parkinson’s disease.
Clinical Trials Research & Development

Double Delight For Novartis At The CHMP

Novartis has received two positive opinions in Europe, the most important being for Mayzent, its active secondary progressive multiple sclerosis drug which is key to the company's ambitions for growth in the neurology space.

Drug Review Europe

Merck Acquires Novel Neurodegenerative Disease Target With Calporta Buy

The deal worth up to $576m gives Merck what Calporta founding investor Avalon believes is the most advanced program targeting TRPML1, a lysosomal ion channel implicated in neurodegenerative diseases when the lysosome stops clearing debris from cells.

Deals Neurology

Roche's pRED Leaders On Its Next Generation Of Drugs

"We're not resting on our laurels," pRED head William Pao said in an early R&D overview. The company's R&D leaders highlighted drugs in oncology, neuroscience and ophthalmology.

Research & Development Neurology
See All

Immunology

Set Alert for Immunology

Latest From Immune Disorders

ResTORbio Pins Hopes On Parkinson’s After Failed CSRI Study

Company terminates studies of its TORC1 blocker after it fails to prevent respiratory illness in elderly patients with clinically symptomatic respiratory illness (CSRI). ResTORbio is hoping the same drug will be effective in Parkinson’s disease.
Clinical Trials Research & Development

HES Flare: GSK's Nucala Edges Forward

GlaxoSmithKline’s interleukin-5 inhibitor, Nucala (mepolizumab), is the first treatment shown to reduce the hypereosinophilic syndrome flare-ups in a 100-patient pivotal study.

 

 

 

Immune Disorders Clinical Trials

European Biotechs Enter the IPO Big League

2019 has seen European biotech companies making waves in the US IPO space. Genmab’s listing was a blockbuster, but many more companies have proven their ability to go public on the NASDAQ.

Europe Commercial

J&J Targets Tremfya Growth In PsA

The healthcare giant is looking for a second approval for its IL-23 blocker and tells Scrip the results from the DISCOVER program show that the drug can make its mark in psoriatic arthritis as well as psoriasis.
Immune Disorders Clinical Trials

AstraZeneca Closer To Filing Anifrolumab For Lupus

Having recovered from a late-stage fail last year, AstraZeneca has fleshed out results from a positive second Phase III trial of anifrolumab which it hopes will be the second new lupus treatment to hit the market in 60 years.

Inflammation Clinical Trials

Novartis's Cosentyx Fails To EXCEED Humira in PsA

The Swiss major's immunology head tells Scrip that while Cosentyx was unable to beat Humira on the 20% improvement scale for symptoms in psoriatic arthritis patients, the totality of the data from the EXCEED study should sway clinicians to use the IL-17 inhibitor as a first-line treatment.
Clinical Trials Immune Disorders
See All

Infectious

Set Alert for Infectious Diseases

Latest From Infectious Diseases

ResTORbio Pins Hopes On Parkinson’s After Failed CSRI Study

Company terminates studies of its TORC1 blocker after it fails to prevent respiratory illness in elderly patients with clinically symptomatic respiratory illness (CSRI). ResTORbio is hoping the same drug will be effective in Parkinson’s disease.
Clinical Trials Research & Development

VBI Looking To Market More Potent, Less Expensive Hepatitis B Vaccine

Sci-B-Vac was shown more effective at fewer doses than Engerix-B in a Phase III study. VBI Vaccines sees its hepatitis B vaccine hitting potential markets by 2021.

Vaccines Infectious Diseases

Merck’s Ervebo Becomes World’s First Approved Ebola Vaccine

Merck Sharp & Dohme will begin manufacturing licensed doses of Ervebo in Germany and will continue to send investigational vaccine doses to Democratic Republic of Congo.

Vaccines Approvals

Scynexis’ Phase III Success Brings New Antifungal Class Closer To Approval

Biotech plans to file its first-in-class triterpenoid agent for approval in 2020 following a second Phase III study in acute vulvovaginal candidiasis. Beyond that, it hopes for a supplemental approval in recurrent VVC.

Business Strategies Clinical Trials

Dengvaxia Beater? Promising But Mixed Results For Takeda’s Dengue Contender

Long-anticipated findings for Japanese firm’s dengue vaccine show efficacy rates above its only rival, including in those not previously exposed to the virus, but results for different strains were mixed and experts are awaiting additional data due in the next few weeks.

Vaccines Clinical Trials

HIV PrEP Patent Dispute Escalates As HHS Files Suit Against Gilead

Trump administration wants the HIV drug maker to license HHS patents related to pre-exposure prophylaxis. Lawsuit follows Gilead’s request in August for the USPTO’s PTAB to conduct an inter partes review of the four-year-old patents.

Intellectual Property Infectious Diseases
See All

Metabolic

Set Alert for Metabolic

Latest From Metabolic Disorders

Novo Nordisk Enters Its First Strategic RNAi Pact

Novo Nordisk’s head of global drug discovery tells Scrip he hopes the strategic collaboration with Dicerna Pharmaceuticals will generate clinical candidates within three years.

Commercial Companies

Zealand Pharma Preps Pipeline For Catalyst-Filled 2020

Zealand Pharma’s recently installed CEO says it is building US operations to prepare for four potential approvals there in 2020, with commercial launches starting in 2021, its first ever.

Companies Research & Development

Amarin Heads Into Vascepa Expansion Labeling Talks After Positive US FDA Panel Review

Focus of negotiations with agency will be on breadth of population encompassed by a cardiovascular risk reduction indication; most advisory committee members favored a broad claim for secondary and primary prevention reflecting the REDUCE-IT trial population, but some strongly opposed an indication that includes patients without established CV disease.

Advisory Committees Drug Review

Staying Diversified, Bayer Sees Opportunities In Digital Innovation

Despite its Monsanto woes, Bayer is sticking with its diversified portfolio, and is branching out into patient-facing digital health services.

Commercial Digital Health

Results Position Esaxerenone For Japan Diabetic Nephropathy Filing

New top-line results from Japanese study set stage for submission of esaxerenone in additional high-need indication.

Metabolic Disorders Clinical Trials

Lilly’s Diabetes Franchise Poised For A Shakeup As Conterno Steps Down

Lilly’s newer diabetes drugs are selling well, although Trulicity numbers disappointed analysts, and are among the firm’s growth-drivers. Longtime diabetes head Enrique Conterno will be succeeded by insider Mike Mason.

Sales & Earnings Business Strategies
See All

Oncology

Set Alert for Oncology

Latest From Cancer

Myovant Ready To File Relugolix For Prostate Cancer

Secondary endpoint assessing cardiovascular risk may offer important differentiation from AbbVie’s Lupron. Myovant accelerated the prostate cancer filing soon after slowing the planned relugolix submission for uterine fibroids.

Clinical Trials Drug Approval Standards

European Biotechs Enter the IPO Big League

2019 has seen European biotech companies making waves in the US IPO space. Genmab’s listing was a blockbuster, but many more companies have proven their ability to go public on the NASDAQ.

Europe Commercial

Staying Diversified, Bayer Sees Opportunities In Digital Innovation

Despite its Monsanto woes, Bayer is sticking with its diversified portfolio, and is branching out into patient-facing digital health services.

Commercial Digital Health

Japan Cancer Center Looks To Leverage Expertise As It Builds Pharma Ties

Japan's largest cancer center is looking to build on its tissue sample and genomic resources to further build its reputation as a partner facility for the pharma industry's oncology trials. 
Japan Cancer

Roche's pRED Leaders On Its Next Generation Of Drugs

"We're not resting on our laurels," pRED head William Pao said in an early R&D overview. The company's R&D leaders highlighted drugs in oncology, neuroscience and ophthalmology.

Research & Development Neurology

ASLAN Falls As TreeTopp BTC Study Fails

ASLAN’s pivotal Phase II TreeTopp study of varlitinib in biliary tract cancer missed its co-primary endpoints of progression-free survival and overall response rate.

Cancer Clinical Trials
See All

Respiratory

Set Alert for Respiratory

Latest From Respiratory

Roche Paying $390m Up Front For Fibrosis-Fighting Promedior

The deal, which includes up to $1bn for milestones, gives Roche Promedior’s PRM-151, a Phase III-ready asset for IPF that has also completed a Phase II study in myelofibrosis and could be effective in a broad range of fibrotic diseases.

Deals M & A

HES Flare: GSK's Nucala Edges Forward

GlaxoSmithKline’s interleukin-5 inhibitor, Nucala (mepolizumab), is the first treatment shown to reduce the hypereosinophilic syndrome flare-ups in a 100-patient pivotal study.

 

 

 

Immune Disorders Clinical Trials

Ambitious AB Science Gets Masitinib Win For Severe Asthma

Plagued by concerns on the integrity of data and compliance issues with its clinical practices, the French firm still believes masitinib could be effective for ALS, multiple sclerosis, cancers, asthma and even Alzheimer's.
Strategy Clinical Trials

GSK Says Shingrix Shortage, Oncology Push Continues

GlaxoSmithKline said its increasingly streamlined operations are on a growth trajectory, but that capacity constraints mean demand for its popular shingles vaccine will keep outstripping supply.

Commercial Companies

Interview: AstraZeneca ‘Is More Than Oncology’

Ruud Dobber oversees AstraZeneca’s biopharmaceuticals division, which generates some 40% of group total revenues. He tells Scrip to “Watch this space.”

Commercial Companies

Vertex Finally Inks Orkambi Deal In England

Vertex has finally managed to reach an agreement to bring its cystic fibrosis drugs Orkambi and Symkevi to patients in England, which constitutes an important slice of what is the second biggest market for the drugs.

Companies Reimbursement
See All
UsernamePublicRestriction

Register