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Merck: As The Sun Rises For Keytruda, It Sets For Zetia/Vytorin

Merck’s focus has shifted increasingly to Keytruda and immuno-oncology, while the company’s older stalwarts like Zetia, Vytorin and Januvia face pressure.

Sales and Earnings Deals Commercial

Merck Says PD-L1 Testing Already On The Rise, Setting Stage For First-Line Launch

Testing for the biomarker has picked up since paradigm changing data in first-line lung cancer was presented at ESMO, management said. Now, with the FDA approval of Keytruda, Merck is focused on establishing a solid lead in a big commercial market.

ImmunoOncology Product Launch Commercial

Stockwatch: Earnings Season Inevitabilities

Johnson & Johnson, Actelion and Roche launched the 2016 third-quarter earnings season with a somewhat mixed opening salvo. The harsh investor response probably reflected an awareness of the inevitability of generic competition.

Financial Reports Companies Commercial

3Q Pharma Results Preview: Novartis, Merck, Lilly, Bayer, GSK, Bristol, Amgen, Sanofi

Johnson & Johnson and Roche launched the big pharma quarterly reporting season. Next up are Novartis, Lilly, Merck, Bayer, GSK, Bristol-Myers Squibb, Amgen and Sanofi. Scrip offers some key points to watch for.

Financial Reports Companies Commercial

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Commercial Explore this Topic

Novartis Chief: Good Things Come To Those Who Wait

In the company’s third-quarter conference call, Novartis CEO Joe Jimenez admitted that generic competition to its blockbuster Gleevec will continue to drag on the company in 2017. However, he touted a pipeline of 12 potential blockbusters and restructuring efforts over the past three years as evidence that the company will be positioned for growth from 2018.

Financial Reports Business Strategies Companies

Can New Drugs Meet Lilly’s Revenue Goals If Solanezumab Fails?

New products continue to drive Lilly’s revenue growth and the company expects that to remain the case even if the final Phase III trial for Alzheimer’s candidate solanezumab fails later this year.

Sales and Earnings Financial Reports Clinical R and D

Latest From Commercial

Ports, Prosthetics Take Blame In Partial Hold For Aduro’s Immunotherapy Trials

Aduro hopes for a relatively quick resolution to a clinical hold for its LADD cancer vaccine studies instituted by the FDA based on listeria detected around indwelling ports in two patients.

Clinical R and D Commercial

It’s Here: Merck’s Keytruda Cleared For First-Line Lung Cancer

The event that the oncology market has been waiting for has arrived. FDA approved Merck’s PD-1 inhibitor Keytruda for first-line treatment of non-small cell lung cancer, a paradigm-changing event that opens up the largest sales segment for immuno-oncology.

Approvals Clinical Trials

GSK Files Blockbuster Hopeful Shingrix With FDA

The shingles vaccine is considered one of the products with the biggest commercial potential for GSK in the near-term.

Vaccines Commercial

Abbott Defines Bullishness On India

The 50th annual general meeting of the Organization of Pharmaceutical Producers of India (OPPI) in Mumbai saw an eclectic mix of leaders from academia, politics, bureaucracy and industry in full attendance. Abbott's bullishness on the Indian market and suggestions for concerted efforts to move the access needle were among the key takeaways of the event.

Commercial India

Biocon Confident As First Biosimilars Seen Hitting Europe In Early 2018

India’s leading biologics company Biocon has said it expects its first biosimilar products to be launched in the European market by early 2018 and is bullish on both its plans in the sector and earnings prospects after reporting quarterly net profit soared by a better than expected 52%.

India Biosimilars

Can An Elephant Crack China’s Bamboo Ceiling For Generics?

Among the many challenges facing foreign generics firms operating in China, dealing with ever-tightening policies and regulations is probably the toughest, and has already forced several multinationals to quit the market. But one Indian joint venture is looking to effectively exploit targeted niche opportunities.

China Business Strategies

Policy & Regulation Explore this Topic

Ono Files Japan Patent Action As Keytruda Nears Market

Hot on the heels of Keytruda's US approval for first-line use in lung cancer, and just ahead of the drug’s first local launch, rival PD-1 player Ono has launched a patent infringement suit in Japan against Merck, adding to similar actions brought elsewhere by its global Opdivo partner BMS.

Patent Litigation Japan Commercial

Turkish Call For Moves To Support Industry ‘Independence’

The chairman of Turkey’s main domestic manufacturers’ association has launched some of his strongest criticism yet of multinationals, accusing them of hindering the local sector’s development and calling on the government to support a more independent Turkish industry. The drug trading role of pharmacists has also come in for attack.

Turkey Policy and Regulation BioPharmaceutical

Latest From Policy and Regulation

GSK Files Blockbuster Hopeful Shingrix With FDA

The shingles vaccine is considered one of the products with the biggest commercial potential for GSK in the near-term.

Vaccines Commercial

Merck & Co Expands C Diff Franchise With US Zinplava Approval

Merck & Co is planning a first-quarter 2017 launch of Zinplava, its novel therapy for use in Clostridium difficile infection, following a US FDA approval, strengthening the company’s leading position in an infectious disease with great unmet need.

Policy and Regulation Product Approvals

NICE OK For BMS's Opdivo To Shake Up UK RCC Market, Bad News For Pfizer

Bristol-Myers Squibb's Opdivo looks set to blow rivals out the water in renal cell carcinoma as NICE U-turns on negative recommendation, just weeks after the company revealed the full extent of the drug’s disappointment in first-line lung cancer.

Health Technology Assessment Commercial

Genentech’s Tecentriq Stakes New Claim With FDA Lung Cancer Approval

Genentech’s PD-L1 inhibitor Tecentriq could steal market share from the PD-1 inhibitors Opdivo and Keytruda in its new indication, but the Roche subsidiary’s drug is a year behind competitors from Bristol-Myers and Merck in NSCLC with seven Phase III trials under way to expand its reach in lung cancer.

Policy and Regulation Commercial

US Treasury’s Final Earnings Stripping Guidance Keeps Pressure On Inversions

The US Treasury released final guidance to eliminate one of the economic motivations behind inversion deals, the threat of which in April derailed the Pfizer/Allergan mega merger. It doesn’t, however, affect other practices as feared.

Business Strategies US Election 2016

From Solanezumab To Solithromycin: What To Watch For In Q4

Lilly’s solanezumab, Roche/Genentech’s Ocrevus and Cempra’s solithromycin are among the key therapies scheduled for major data read-outs or approval decisions in Q4 2016. With the help of Informa Pharma Intelligence’s Biomedtracker, Scrip takes a look at what to expect before we enter the new year.

Clinical R and D Policy and Regulation

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Daiichi Presses On With Lead Pexidartinib Trial Despite Liver Toxicity

Daiichi Sankyo is to continue with a multinational Phase III trial for its novel candidate for tenosynovial giant cell tumor despite cases of liver toxicity, but has stopped enrolment short of target and modified the protocol.

Cancer Product Safety Clinical R and D

INFOGRAPHIC: Mental Health; A Road Still Less Travelled By Pharma

The scope of mental disorders and increasing patient numbers represent opportunity for pharma and biotech, but historically these conditions have carried high risk/low success rate labels. As the number of patients continues to grow with the world's expanding and aging population, voids in available drug treatments for some conditions will become more apparent.

BioPharmaceutical Clinical R and D Therapy Areas

Latest From Clinical R and D

Ports, Prosthetics Take Blame In Partial Hold For Aduro’s Immunotherapy Trials

Aduro hopes for a relatively quick resolution to a clinical hold for its LADD cancer vaccine studies instituted by the FDA based on listeria detected around indwelling ports in two patients.

Clinical R and D Commercial

If Alkermes Antidepressant Can Get Past FDA, The Market Might Be There

Alkermes’s announcement of positive findings in the FORWARD-5 trial of its treatment-resistant depression drug ALKS 5461 came as a surprise, given the past two Phase III trials disappointed, but if it can gain approval, the buprenorphine/samidorphan product could meet an unmet need.

Clinical Trials Clinical R and D

Keytruda, Opdivo Set To Challenge Tecentriq In Bladder Cancer

Phase III trial of Merck's Keytruda stops early with survival benefit as FDA accepts filing of Bristol's Opdivo, which has breakthrough therapy status and priority review.

Cancer Clinical Development and Trials

PIPELINE WATCH: New Diabetes Therapy Studied In China, DARPins Progress In Eye Disease

Pipeline Watch has been updated to bring greater depth and detail to a potential therapeutic product’s progress through the R&D pipeline. The table brings you a snapshot of selected late-stage clinical trial events in the pharma and biotech industries.

Pipeline Watch Approvals

Roche's Post-Avastin Strategy Stumbles As Vanucizumab Fails In Phase II

Roche's development plans for a follow-on Avastin product have been called into question after the company noted briefly in its third-quarter earnings update that the drug failed in a Phase II study in colorectal cancer patients.

Business Strategies Cancer

Modus's Intended IPO to Spur Sickle Cell Drug R&D

The first IPO for a pharmaceutical company nurtured by Karolinska Development is expected to involve Modus Therapeutics, which has changed its name from Dilaforette and is pursuing the development of a Phase II potential sickle cell therapy.

Financing Clinical R and D