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Latest Pharma Insights


Oncology: Tissue-Agnostic Indications Advance Under US FDA's Breakthrough Umbrella
Merck's Keytruda may not be only oncologic with indication for cancer patients defined by molecular signature, not tissue of origin...
The Pink Sheet - May 25, 2017
J&J Settlement With States Not Likely To Be Precedent In OTC Space
J&J's agreement with 42 states and Washington, D.C. is its latest cost from widespread GMP problems that prompted recalls and...
The Pink Sheet - May 25, 2017
GW's Epidolex Epilepsy Data Paves Way For Cannabinoids
Safety and efficacy in study published in New England Journal of Medicine bode well for cannabinoid therapy Epidiolex, which is...
Scrip - May 25, 2017
US FDA's Gottlieb Wants Safety Built Into New Medtech Products, But Budget Will Be Cut To Surveil Older Ones
President Trump's proposed budget cuts to the agency's post-market surveillance programs means that more "faulty" devices, such as St. Jude...
Medtech Insight - May 25, 2017
HHS Action On Drug Pricing: Here's Who Secretary Price Is Listening To
HHS is expected to move ahead with action to address high drug prices following a series of stakeholder roundtables held...
The Pink Sheet - May 25, 2017
Patient Group Collaboration In Rare Diseases Offers Model For Cell/Gene Therapy Firms
Companies doing groundbreaking work in cell and gene therapies should look to how rare disease drug developers partnered with patient...
Scrip - May 25, 2017
Deal Watch: Takeda Signs Broad Cancer Collaboration With Nektar
Takeda will pair five cancer candidates with different mechanisms of action with Nektar's NKTR-214 and Merck follows up its Phase...
Scrip - May 25, 2017
Biosimilar Advisory Committees Getting Smoother, Even As Worries Stay The Same
US FDA advisors overwhelming endorse Hospira's biosimilar referencing Amgen's Epogen, but still wanted broader immunogenicity data and postmarketing surveillance.
The Pink Sheet - May 25, 2017
Sickle Cell Innovators Required: Emmaus' Pending Approval Highlights Rare Disease Void
FDA approval is likely for Emmaus' sickle cell drug L-glutamine this summer, representing the first new product for the disease...
Scrip - May 25, 2017
Qualcomm: A New Kind Of Medical Device Company
The mobile-technology company is trying to corner the wireless needs of the health-care industry, and is pushing for adoption of...
Medtech Insight - May 25, 2017
FDA Tip-Toes In China To Push Data Integrity, Harmonization
US FDA warning letters to Chinese firms may be on the increase, but ties with the Chinese regulator appear to...
The Pink Sheet - May 25, 2017
FDA, EU To Redouble Inspection Of Asian Pharmaceutical Supply Chains
Mutual recognition agreement enables US and European authorities to redirect inspectional resources to China and India. The result could be...
The Pink Sheet - May 25, 2017
Medtronic Hits Targets In "Solid" Fiscal 2017
Medtronic, medtech's number one player, did not disappoint the market with its final fiscal quarter performance. With revenue and profit...
Medtech Insight - May 25, 2017
Gifts For Industry: From Waived Inspections To Pre-Market Leeway, US FDA Woos Firms For Maturity Pilot
FDA wants to give away a basket of goodies to manufacturers that voluntarily play in an upcoming pilot program that...
Medtech Insight - May 25, 2017
Bring On Clinical Studies: China Steps Up To Facilitate New Drug Entry
Allowing early stage Phase I studies, setting a 60-day period for IND approvals, and dropping a requirement for hospital to...
The Pink Sheet - May 25, 2017
FDA To Curtail Cosmetics Safety Work Under FY 2018 Budget Constraints
President Trump's budget proposal for fiscal 2018 calls for "targeted reductions to the Food Safety program, including reducing staff levels...
The Rose Sheet - May 25, 2017
Roadmap To Improve EMA’s Medical Literature Monitoring Service Due Soon
A roadmap to improve the European Medicines Agency’s medical literature monitoring service will be published soon. While some of industry’s...
The Pink Sheet - May 25, 2017
Chronic Hepatitis D Among Targets Of Latest Drugs On EMA’s PRIME Scheme
The latest five products to make it onto the European Medicines Agency’s priority medicines (PRIME) scheme for products target a...
The Pink Sheet - May 25, 2017
PML Case With Roche's Ocrevus, Link Unlikely
A German case of PML in a patient treated with Ocrevus, but who was also previously treated with Tysabri, threatens...
Scrip - May 25, 2017
Three CHMP Negative Opinions ? But Who Got A Boon?
The European Medicines Agency's advisory committee, the CHMP, unusually issued three negative opinions at its recent monthly meeting. Which companies...
Scrip - May 25, 2017
SMEs Making The Most Of EU Centralized Procedure And Scientific Support From EMA
Smaller biopharmaceutical firms are increasingly making use of the EU’s centralized approvals procedure and the EMA’s scientific advice and other...
The Pink Sheet - May 25, 2017
Appointments: IFPMA, Merck, Chromocell, Kymab, GW Pharmaceuticals, Fortuna Fix and Motif
This week's roundup includes high level appointments by Merck KGaA, Chromocell Corporation, Kymab and GW Pharmaceuticals, in addition to board...
Scrip - May 25, 2017
Number To Know…330
Medtronic has initiated the pivotal study of its In.Pact AV Access drug-coated balloon and expects to enroll 330 patients.
Medtech Insight - May 25, 2017
Commission Delays EU GMP Guide For Advanced Therapies To Address Inspectorates’ Concerns
The finalization of the EU GMP guideline for advanced therapy medicinal products has been pushed back as the European Commission...
The Pink Sheet - May 25, 2017
VIDEO: Korean Pharma Spawns US Cancer Biotech Startup
Dr. Benjamin R Cowen, COO of ImmunoMet Therapeutics, reveals how the Houston-based startup is developing OXPHOS inhibitors to treat drug...
Scrip - May 25, 2017
Celltrion Gets Go-Ahead For Remsima Trials In China, Mulls JV
Celltrion has received approval to begin clinical trials of its biosimilar infliximab in China and also filed IND applications for...
Scrip - May 25, 2017
US Price Pressure Clouds Lupin Outlook – Can Its Pipeline Deliver?
Lupin reported a sharp decline in its fourth quarter profits, dented by heightened price pressure and competition in the US...
Scrip - May 25, 2017

GW's Epidolex Epilepsy Data Paves Way For Cannabinoids
Safety and efficacy in study published in New England Journal of Medicine bode well for cannabinoid therapy Epidiolex, which is...
Scrip - May 25, 2017
Patient Group Collaboration In Rare Diseases Offers Model For Cell/Gene Therapy Firms
Companies doing groundbreaking work in cell and gene therapies should look to how rare disease drug developers partnered with patient...
Scrip - May 25, 2017
Deal Watch: Takeda Signs Broad Cancer Collaboration With Nektar
Takeda will pair five cancer candidates with different mechanisms of action with Nektar's NKTR-214 and Merck follows up its Phase...
Scrip - May 25, 2017
Sickle Cell Innovators Required: Emmaus' Pending Approval Highlights Rare Disease Void
FDA approval is likely for Emmaus' sickle cell drug L-glutamine this summer, representing the first new product for the disease...
Scrip - May 25, 2017
PML Case With Roche's Ocrevus, Link Unlikely
A German case of PML in a patient treated with Ocrevus, but who was also previously treated with Tysabri, threatens...
Scrip - May 25, 2017
Three CHMP Negative Opinions ? But Who Got A Boon?
The European Medicines Agency's advisory committee, the CHMP, unusually issued three negative opinions at its recent monthly meeting. Which companies...
Scrip - May 25, 2017
Appointments: IFPMA, Merck, Chromocell, Kymab, GW Pharmaceuticals, Fortuna Fix and Motif
This week's roundup includes high level appointments by Merck KGaA, Chromocell Corporation, Kymab and GW Pharmaceuticals, in addition to board...
Scrip - May 25, 2017
VIDEO: Korean Pharma Spawns US Cancer Biotech Startup
Dr. Benjamin R Cowen, COO of ImmunoMet Therapeutics, reveals how the Houston-based startup is developing OXPHOS inhibitors to treat drug...
Scrip - May 25, 2017
Celltrion Gets Go-Ahead For Remsima Trials In China, Mulls JV
Celltrion has received approval to begin clinical trials of its biosimilar infliximab in China and also filed IND applications for...
Scrip - May 25, 2017
US Price Pressure Clouds Lupin Outlook – Can Its Pipeline Deliver?
Lupin reported a sharp decline in its fourth quarter profits, dented by heightened price pressure and competition in the US...
Scrip - May 25, 2017

Oncology: Tissue-Agnostic Indications Advance Under US FDA's Breakthrough Umbrella
Merck's Keytruda may not be only oncologic with indication for cancer patients defined by molecular signature, not tissue of origin...
The Pink Sheet - May 25, 2017
J&J Settlement With States Not Likely To Be Precedent In OTC Space
J&J's agreement with 42 states and Washington, D.C. is its latest cost from widespread GMP problems that prompted recalls and...
The Pink Sheet - May 25, 2017
HHS Action On Drug Pricing: Here's Who Secretary Price Is Listening To
HHS is expected to move ahead with action to address high drug prices following a series of stakeholder roundtables held...
The Pink Sheet - May 25, 2017
Biosimilar Advisory Committees Getting Smoother, Even As Worries Stay The Same
US FDA advisors overwhelming endorse Hospira's biosimilar referencing Amgen's Epogen, but still wanted broader immunogenicity data and postmarketing surveillance.
The Pink Sheet - May 25, 2017
FDA Tip-Toes In China To Push Data Integrity, Harmonization
US FDA warning letters to Chinese firms may be on the increase, but ties with the Chinese regulator appear to...
The Pink Sheet - May 25, 2017
FDA, EU To Redouble Inspection Of Asian Pharmaceutical Supply Chains
Mutual recognition agreement enables US and European authorities to redirect inspectional resources to China and India. The result could be...
The Pink Sheet - May 25, 2017
Bring On Clinical Studies: China Steps Up To Facilitate New Drug Entry
Allowing early stage Phase I studies, setting a 60-day period for IND approvals, and dropping a requirement for hospital to...
The Pink Sheet - May 25, 2017
Roadmap To Improve EMA’s Medical Literature Monitoring Service Due Soon
A roadmap to improve the European Medicines Agency’s medical literature monitoring service will be published soon. While some of industry’s...
The Pink Sheet - May 25, 2017
Chronic Hepatitis D Among Targets Of Latest Drugs On EMA’s PRIME Scheme
The latest five products to make it onto the European Medicines Agency’s priority medicines (PRIME) scheme for products target a...
The Pink Sheet - May 25, 2017
SMEs Making The Most Of EU Centralized Procedure And Scientific Support From EMA
Smaller biopharmaceutical firms are increasingly making use of the EU’s centralized approvals procedure and the EMA’s scientific advice and other...
The Pink Sheet - May 25, 2017
Commission Delays EU GMP Guide For Advanced Therapies To Address Inspectorates’ Concerns
The finalization of the EU GMP guideline for advanced therapy medicinal products has been pushed back as the European Commission...
The Pink Sheet - May 25, 2017

EU Medtechs Keep Open Mind On HTA Options In Wider Market Access Plan
Health technology assessment for medtech products in Europe is a strictly national responsibility, but is there a case for an...
IN VIVO - May 24, 2017
Schilsky On ASCO 2017: The “You” Factor In Cancer Care
ASCO’s 2017 annual meeting is expanding its focus on patient wellness beyond the clinic, with new research highlighting prevention, alternative...
IN VIVO - May 24, 2017
ASCO’s Research Agenda: Widening The Circle Of Care
In Vivo's analysis of ASCO 2017’s abstract database reveals that patient well-being is a primary area of focus.
IN VIVO - May 24, 2017

US FDA's Gottlieb Wants Safety Built Into New Medtech Products, But Budget Will Be Cut To Surveil Older Ones
President Trump's proposed budget cuts to the agency's post-market surveillance programs means that more "faulty" devices, such as St. Jude...
Medtech Insight - May 25, 2017
Qualcomm: A New Kind Of Medical Device Company
The mobile-technology company is trying to corner the wireless needs of the health-care industry, and is pushing for adoption of...
Medtech Insight - May 25, 2017
Medtronic Hits Targets In "Solid" Fiscal 2017
Medtronic, medtech's number one player, did not disappoint the market with its final fiscal quarter performance. With revenue and profit...
Medtech Insight - May 25, 2017
Gifts For Industry: From Waived Inspections To Pre-Market Leeway, US FDA Woos Firms For Maturity Pilot
FDA wants to give away a basket of goodies to manufacturers that voluntarily play in an upcoming pilot program that...
Medtech Insight - May 25, 2017
Number To Know…330
Medtronic has initiated the pivotal study of its In.Pact AV Access drug-coated balloon and expects to enroll 330 patients.
Medtech Insight - May 25, 2017

FDA To Curtail Cosmetics Safety Work Under FY 2018 Budget Constraints
President Trump's budget proposal for fiscal 2018 calls for "targeted reductions to the Food Safety program, including reducing staff levels...
The Rose Sheet - May 25, 2017

Marketed Drugs: Hepatitis C
Despite additional competition from Merck & Co’s Zepatier, which has already superseded Viekira Pak as the main rival to Harvoni in the US, Gilead is expected to retain its dominant position in GT-1/4 patients because of its first-to-market status and willingness to match the discounts offered by rivals. As the first-to-market pan-genotypic regimen, Epclusa is well-positioned to replace Sovaldi as the standard of care for GT-2/3 patients. (Hepatitis C : Marketed Drugs )
Datamonitor Healthcare - May 24, 2017
Pipeline: Hepatitis C
Sofosbuvir/velpatasvir/voxilaprevir’s failure to demonstrate non-inferiority to 12 weeks of Epclusa as an eight-week course has resulted in its positioning as a 12-week salvage regimen for patients failing first-line direct-acting antiviral therapy. Glecaprevir/pibrentasvir will pose fierce competition to Gilead’s Epclusa in GT-2/3/4/5/6 patients because of its anticipated shorter eight-week duration in non-cirrhotic patients. (Hepatitis C : Pipeline )
Datamonitor Healthcare - May 24, 2017
Epclusa
Epclusa is the first pan-genotypic regimen approved for the treatment of chronic hepatitis C virus infection, and brings further improvements in cure rates for genotype 2/3 patients. Sovaldi is currently the recommended option for GT-3 patients, but it possesses only moderate efficacy and must be taken in an expensive 12-week combination with Daklinza or a 24-week combination with ribavirin to achieve acceptable cure rates. (Epclusa : Product Analysis )
Datamonitor Healthcare - May 24, 2017
Sovaldi
Sovaldi was the first interferon-free regimen to be approved for genotype 2/3 (GT-2/3) patients, and has greatly benefited from the lucrative warehoused population and lack of competitors in this subgroup. However, Sovaldi’s GT-2/3 sales, derived from its use in combination with either ribavirin or Daklinza, are rapidly declining due to cannibalization of its patient share by Gilead’s own pan-genotypic successor regimen, Epclusa. (Sovaldi : Product Analysis )
Datamonitor Healthcare - May 24, 2017
Sunvepra
Sunvepra is an NS3 protease inhibitor approved in Japan for the treatment of genotype 1 (GT-1) chronic hepatitis C virus infections in combination with Daklinza. Since the Japanese approvals of Harvoni and Viekirax in July 2015 and September 2015, respectively, sales of Sunvepra have undergone a steep decline. By the end of H1 2017, Datamonitor Healthcare expects that Gilead's and AbbVie's oral regimens will have fully replaced Sunvepra + Daklinza as the standard of care for GT-1 patients. (Sunvepra : Product Analysis )
Datamonitor Healthcare - May 24, 2017
Olysio
Olysio's use for the treatment of hepatitis C in the US, Japan, and five major EU markets (France, Germany, Italy, Spain, and the UK) is expected to cease in 2017 as the widespread launches of Harvoni, Viekira Pak, and Zepatier have rendered its use in combination with Sovaldi clinically redundant. Indeed, sales of Olysio in 2016 totaled just $106m, compared to $2,302m and $621m in 2014 and 2015, respectively. (Olysio : Product Analysis )
Datamonitor Healthcare - May 24, 2017
Daklinza
Datamonitor Healthcare expects Daklinza’s sales to continue to plummet throughout 2017 as it is forced out of its lucrative genotype 3 niche by Gilead’s substantially cheaper but highly effective pan-genotypic regimen, Epclusa. Within the US, Epclusa’s June 2016 approval has rendered the use of the highly expensive combination of Daklinza + Sovaldi non cost-effective, triggering a 50% decline in Daklinza’s sales from $553m in H1 2016 to $274m in H2 2016. (Daklinza : Product Analysis )
Datamonitor Healthcare - May 24, 2017
Zepatier
Following its US launch in January 2016, Zepatier has already superseded Viekira Pak as the main rival to Harvoni because of its more convenient once-daily dosing schedule and lack of requirement for ritonavir boosting. Zepatier is also expected to usurp Viekira Pak’s position in the five major EU markets (France, Germany, Italy, Spain, and the UK), although its uptake in these markets has been delayed by its later July 2016 approval and the need to conduct pricing and reimbursement negotiations. (Zepatier : Product Analysis )
Datamonitor Healthcare - May 24, 2017
Harvoni
Harvoni is the current standard of care for genotype 1 (GT-1) and GT-4 chronic hepatitis C virus patients because of its excellent efficacy and convenient once-daily, ribavirin-free dosing schedule. Despite facing fierce pricing competition from Viekira Pak and Zepatier, which have displayed comparable efficacy and tolerability in Phase III studies, Gilead has been able to retain its dominant position by increasing the discounts offered to payers. (Harvoni : Product Analysis )
Datamonitor Healthcare - May 24, 2017
Ximency
Ximency is Bristol-Myers Squibb’s second interferon-free regimen targeted at the Japanese market, and is positioned as a 12-week replacement for the currently marketed 24-week combination of Daklinza + Sunvepra. As a fifth-to-market interferon-free regimen with an inconvenient twice-daily dosing schedule and lack of differentiation based on efficacy or tolerability, Datamonitor Healthcare expects Ximency will have a minimal impact on the market share of the earlier-launched once-daily regimens. (Ximency : Product Analysis )
Datamonitor Healthcare - May 24, 2017
sofosbuvir/velpatasvir/voxilaprevir
Sofosbuvir/velpatasvir/voxilaprevir is Gilead’s third-generation interferon-free regimen, which is being positioned as a 12-week salvage regimen for patients who have previously failed direct-acting antiviral therapy. While Gilead had hoped that eight weeks of treatment with SOF/VEL/VOX would display non-inferior efficacy to 12 weeks of Epclusa in GT-1/2/3/4/5/6 patients in the pivotal head-to-head POLARIS-2 study, SOF/VEL/VOX failed to meet the pre-specified non-inferiority criteria. (sofosbuvir/velpatasvir/voxilaprevir : Product Analysis )
Datamonitor Healthcare - May 24, 2017
glecaprevir/pibrentasvir
Glecaprevir/pibrentasvir (G/P) is AbbVie's next-generation, pan-genotypic regimen, which is being developed as a replacement for Viekira Pak. G/P is forecast to achieve greater commercial success than its predecessor, and will allow AbbVie to recoup the genotype-1/4 patient share lost to Zepatier throughout 2016 because of its more attractive once-daily ritonavir- and ribavirin-free dosing schedule, as well as its expected broader label for use across all genotypes. (glecaprevir/pibrentasvir : Product Analysis )
Datamonitor Healthcare - May 24, 2017