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Featured Stories


Novo Nordisk Makes Long-Term Bet On GBM Technology With Ziylo Buy

Novo Nordisk has bought UK-based start-up Ziylo in hopes of accelerating development of glucose-responsive insulins, but admits any such products are at least ten years away.

Deals Commercial Companies

Bristol's Opdivo Enjoys IO First-Mover Advantage In Small Cell Lung Cancer

In addition to Opdivo, three other PD-1/L1 inhibitors are in late-stage development for a high-unmet need disease, including Roche's Tecentriq, which will be filed as soon as possible.

Research & Development ImmunoOncology Approvals

Regeneron's Less Frequent Eylea Dosing Makes Late Sprint Across FDA Finish Line

Regeneron's blockbuster AMD biologic Eylea improved its ability to compete with future longer-acting VEGF inhibitors with a label supporting every dosing every 12 weeks; the company's less frequent regimen cleared FDA five days after receiving a complete response letter.

Approvals Ophthalmic Business Strategies
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Formulation In The Drug Product Development Process

Rentschler Biopharma, Leukocare Biotechnology and Pharma Intelligence are undertaking a brief survey to gather insight into the importance, expectations and common challenges of drug product formulation. Each respondent to complete the survey will get a chance to win one of four $50 Visa gift cards.

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First In 10 Years, But Lenvima's First-Line Liver Label Could Be Challenged Soon

Eisai and Merck won the first US FDA approval in 10 years for a first-line hepatocellular carcinoma treatment with Lenvima, but challengers are on the horizon. The companies' recent partnership and plans for combination therapy with Keytruda may defend the drug's standing in liver cancer.

Approvals Clinical Trials Cancer

Sun Hopes Cequa’s Nano Formulation Makes Big Impact

Sun’s now-approved higher concentration, quicker-acting formulation of cyclosporine A could offer competitive advantage in dry eye versus Allergan’s Restasis, but is it enough to offset lower costs of pending generic cyclosporines?

Approvals Business Strategies Commercial

Biosimilar Infliximab Success Paves The Way For Adalimumab In Europe

With the impending European launch of Humira biosimilar adalimumab in October, Scrip talks to some of those in the region that have experience in launching commercially successful biosimilars about uptake, discounts and payer attitudes.

Biosimilars Commercial

Deal Watch, Licensing Focus: Roche, Sanofi Exit Ongoing Anticalin Development Efforts With Pieris

Sarepta licenses gene therapy candidate from Lacerta, also makes equity investment. Neuren licenses North American rights to rare disease drug trofinetide to Acadia.

Deals Business Strategies

In Conversation With Novo Nordisk CMO: The Ongoing Fight Against Diabetes

Stephen Gough has kept his connections with Oxford University and will see collaborations between the two expand next month with the opening of the Novo Nordisk Research Centre Oxford. The executive spoke to Scrip.

Leadership Research and Development Strategies

CVS Sees Growing Physician, Patient Use Of Real-Time Drug Price Data

Prescribers are reviewing patient benefits information nearly 280,000 times per week while patients are using an online Check Drug Cost tool 250,000 times per month – and the numbers are growing.

Private Payers Pricing Strategies

Enthusiasm For US Biosimilars Wanes For Some, But Not Others

Three years after the first biosimilar launched in the US, the market has failed to deliver notable return on investments. Some players like Mylan are going public with frustrations over market barriers, while others, like Amgen, say they are encouraged by steady progress. Teva, however, is limiting its investment in biosimilars.

Biosimilars Commercial

Finance Watch: Vaccinex, Aridis Launch August's First US IPOs As The Summer Simmer Slows

The summer slowdown finally seems to have hit the US biopharma IPO market; after a hot July with nine offerings, there were just two during the first half of August. Also, Zogenix leads recent follow-ons with a $312m offering; venture capital planted in UK biotechs – Orchard and Blueberry.

Financing Business Strategies

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Pharma Industry Braces For Tough Times In Turkey As Turkish Lira Fluctuates

In the recent crisis between Turkey and the US, the Turkish lira went down in value against major currencies, including the euro. In Turkey, product prices are determined on the basis of the euro, for which the government applies a fixed rate. As the difference between the two conversion rates grows, companies lose out forcing the industry to search for ways to cut its losses.

Turkey Emerging Markets Commercial

How Big A Blow To Biogen Is NICE 'No' For Spinraza?

The US biotech is aghast that the cost-effectiveness committee for England, Wales and Northern Ireland is minded to reject its effective but pricey SMA therapy which has gained blockbuster status already on strong sales elsewhere in Europe and the US.

United Kingdom Cost Effectiveness

Regeneron's Extended Eylea Dosing Plan Suffers US FDA Delay

Competitors are moving forward on wet AMD products with longer dosing intervals, with Novartis close to filing with FDA.
FDA Regulation

Insmed’s Amikacin Moves Closer To US Market In Refractory Lung Disease

FDA panel's recommendation that liposome inhalation suspension be labeled only for refractory nontuberculous mycobacterial lung disease and not first-line use aligns with analyst expectations; panel cites lack of clinical studies in treatment-naive patients and adverse event profile as reasons for limiting drug to patients with limited or no treatment options.


Infectious Diseases Respiratory

Research & Development Explore this Topic

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Pipeline Watch: Phase III Starts In ALS And Lupus

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

 

Pipeline Watch Approvals Research & Development

Biohaven Readies Glutamate Modulator BHV-0223 For Phase III In Anxiety

Glutamate modulators could play a role in a range of central nervous system disorders, including social anxiety, amyotrophic lateral sclerosis. Biohaven's first – a reformulation of a generic ALS drug – could be on the market in two years.

Research & Development Neurology

Regeneron And Teva's Fasinumab Crosses One Threshold; More Remain

The companies reported positive Phase III data testing the nerve growth factor inhibitor in patients with chronic pain, but the efficacy appears modest and safety will remain a question until long-term Phase III data read out. The companies are focused on a lower 1 mg dose.

Clinical Trials Neurology

ViiV/Janssen's Long-Acting Anti-HIV Injections Impress

A dual regimen consisting of long-acting injectable formulations of the integrase inhibitor cabotegravir and the nnRTI rilpivirine was as effective as the oral standard-of-care regimen of three drugs daily, in interim results from the ATLAS study.

 

Clinical Trials Infectious Diseases
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