Insights

Insights+: The US FDA New Drug Approvals in August 2021

The US FDA has approved 3 BLAs and 2 NDAs in 2021, leading to treatments for patients and advances in the health care industry The Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) have approved 48 novel products in 2021 Additionally, last year in 2020, the US FDA …

Insights+: The US FDA New Drug Approvals in August 2021 Read More »

4 ways emerging pharma companies can harness marketing content

Rapid creation of compliant marketing content is increasingly important and there are ways emerging pharma companies can stay ahead of the game – despite having fewer resources than bigger firms. A new pharma marketing content ebook from Veeva looks at best practices for building a content foundation that can enable long-term growth. It explains how …

4 ways emerging pharma companies can harness marketing content Read More »

Insights+ Key Biosimilars Events of August 2021

Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency Biosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and the patients During the month of August, Samsung Bioepis’ Byooviz (biosimilar, ranibizumab) received EC’s …

Insights+ Key Biosimilars Events of August 2021 Read More »

Insights+: The US FDA New Drug Approvals in July 2021

The US FDA has approved 6 NDAs in 2021, leading to treatments for patients and advances in the health care industry The Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) have approved 43 novel products in 2021 Additionally, last year in 2020, the US FDA has approved 121 …

Insights+: The US FDA New Drug Approvals in July 2021 Read More »

Insights+ Key Biosimilars Events of July 2021

Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency Biosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and the patients During the month of Jul, Viatris & Biocon’s Semglee got the US …

Insights+ Key Biosimilars Events of July 2021 Read More »

PharmaShots Celebrates Successful Accomplishment of Three Years

Shots: PharmaShots has started its journey in July 2018 as a concise, real-time news delivery platform and is proud to announce the completion of three years, with many more to come. Till now, PharmaShots has published 5,000+ posts with 10000+ subscribers With the completion of three years journey, PharmaShots is proud to announce the “PharmaShots …

PharmaShots Celebrates Successful Accomplishment of Three Years Read More »

Insights+: The US FDA New Drug Approvals in June 2021

The US FDA has approved 6 NDAs and 2 BLAs in 2021, leading to treatments for patients and advances in the health care industry The Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) have approved 37 novel products in 2021 Additionally, last year in 2020, the US FDA …

Insights+: The US FDA New Drug Approvals in June 2021 Read More »

ViewPoints Interview: BeyondSpring’s Dr. Ramon Mohanlal Shares Insights on the Data of Triple Combo Plinabulin Presented at ASCO 2021

In an interview with PharmaShots, Ramon Mohanlal, M.D., Ph.D., MBA, Chief Medical Officer and Executive Vice President of Research and Development at BeyondSpring share his views on the data of triple combination regimen presented at ASCO and also shed light on the impact of plinabulin on SCLC. Shots: Plinabulin in combination with nivolumab and ipilimumab …

ViewPoints Interview: BeyondSpring’s Dr. Ramon Mohanlal Shares Insights on the Data of Triple Combo Plinabulin Presented at ASCO 2021 Read More »

PharmaShots’ Key Highlights of Second Quarter 2021

The second quarter of 2021 witnesses major acquisitions, approvals, and clinical data. There are major alliances in this quarter which include Merck signed ~$1.2B supply agreement with US Government for Molnupiravir to treat COVID-19 The big acquisition took place during the quarter including Microsoft acquired Nuance for ~$19.7B, MorphoSys acquired Constellation for ~$1.7B Our team …

PharmaShots’ Key Highlights of Second Quarter 2021 Read More »

Insights+ Key Biosimilars Events of June 2021

Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency Biosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and the patients During the month of Jun, Celltrion launched Remsima SC (biosimilar, infliximab) for …

Insights+ Key Biosimilars Events of June 2021 Read More »

Insights+: The US FDA New Drug Approvals in May 2021

The US FDA has approved 4 NDAs and 1 BLAs in  2021, leading to treatments for patients and advances in the health care industry. The Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) have approved 29 novel products in 2021. Additionally, last year in 2020, the US FDA …

Insights+: The US FDA New Drug Approvals in May 2021 Read More »

Insights+ Key Biosimilars Events of May 2021

Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency Biosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and the patients During the month of May, Samsung initiated patient enrollment in the P-III …

Insights+ Key Biosimilars Events of May 2021 Read More »

ViewPoints Interview: Aurinia’s Neil Solomons Shares Insights on the Lupkynis

In an interview with PharmaShots, Neil Solomons, Co-founder and Chief Medical Officer of Aurinia shared his views on the data of Lupkynis (voclosporin) presented at the National Kidney Foundation 2021 Spring Clinical Meetings. Shots: New data analysis from the AURORA and AURA clinical studies shows that Aurinia’s therapy demonstrated efficacy across all LN biopsy classes. These data …

ViewPoints Interview: Aurinia’s Neil Solomons Shares Insights on the Lupkynis Read More »

ViewPoints Interview: Medidata’s Anthony Costello Shares Insights on the Transformative Sensor Cloud Platform for Connected Devices and Wearable Sensors in Clinical Trials

In an interview with PharmaShots, Anthony Costello, President, Patient Cloud at Medidata share his views on the launch of Sensor Cloud which is a transformative platform for managing a sensor and digital health technology data during the clinical trials. Shots: The company launches Sensor Cloud for managing sensor and digital health technology data during the …

ViewPoints Interview: Medidata’s Anthony Costello Shares Insights on the Transformative Sensor Cloud Platform for Connected Devices and Wearable Sensors in Clinical Trials Read More »

Insights+: The US FDA New Drug Approvals in April 2021

The US FDA has approved 3 NDAs and 2 BLAs in April 2021, leading to treatments for patients and advances in the health care industry. The Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) have approved 24 novel products in 2021. Additionally, last year in 2020, the US …

Insights+: The US FDA New Drug Approvals in April 2021 Read More »

Insights+ Key Biosimilars Events of April 2021

Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency Biosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and the patients During the month of April, Biocon and Viatris received EC’s approval for …

Insights+ Key Biosimilars Events of April 2021 Read More »

ViewPoints Interview: Dr. Drew Falconer Shares Insights on the Abbott’s NeuroSphere Virtual Clinic

In an interview with PharmaShots, Dr. Drew Falconer, Neurologist and Director at Inova Parkinson’s and Movement Disorders Center in Fairfax, Va. shares insights on the first neurostimulation technology in US that allows patients to receive treatment from doctor without leaving home. Shots: Abbott launches NeuroSphere Virtual Clinic that allows patients to communicate with their physicians, …

ViewPoints Interview: Dr. Drew Falconer Shares Insights on the Abbott’s NeuroSphere Virtual Clinic Read More »

A digital health roadmap for pharma, medical devices and insurance tech

COVID-19 has massively accelerated the uptake of digital health technology across the whole ecosystem, with important implications for pharma, medical device and insurance tech companies. The key trends for these sectors are identified and analysed in a new white paper from Healthware Group that offers guidance on how companies can best adjust to the new …

A digital health roadmap for pharma, medical devices and insurance tech Read More »

ViewPoints Interview: Dr. Robert Koenekoop Shares Insights on Stellar Study Evaluating ProQR’s QR-421a

In an interview with PharmaShots, Dr. Robert Koenekoop, MD, PhD, Professor of Pediatric Surgery, Human Genetics and Adult Ophthalmology at McGill University’s Montreal Children’s Hospital shared his views on the clinical data of the trial and shed light on how RNA therapies work in eye disorders? Shots: QR-421a demonstrated a concordant benefit in multiple measures …

ViewPoints Interview: Dr. Robert Koenekoop Shares Insights on Stellar Study Evaluating ProQR’s QR-421a Read More »

ViewPoints Interview: Artelo Bio’s Dr. Saoirse O’Sullivan Shares Insights on Synthetic Cannabinoid for Cancer Anorexia

In an interview with PharmaShots, Dr. Saoirse O’Sullivan, Ph.D., Scientific Advisor to Artelo Bio shares insights on new cannabinoids, their relevancy, and the other opportunities that can arise from modulating the ECS. Shots: The endocannabinoid system is a network of neurotransmitters and receptors throughout the body that can have a significant impact on improving human health …

ViewPoints Interview: Artelo Bio’s Dr. Saoirse O’Sullivan Shares Insights on Synthetic Cannabinoid for Cancer Anorexia Read More »

PharmaShots’ Key Highlights of First Quarter 2021

The first quarter of 2021 highlights new approvals, M&A, and the clinical data of COVID-19 vaccines. The companies expand their working in COVID-19 by targeting South African & Brazil variants along with other emerging variants Starting with the latest acquisition, Amgen acquired Five Prime for $1.9B, Jazz acquired JW while Boston acquired Preventice. This quarter …

PharmaShots’ Key Highlights of First Quarter 2021 Read More »

Insights+: The US FDA New Drug Approvals in March 2021

The US FDA has approved 7 NDAs in Mar 2021, leading to treatments for patients and advances in the health care industry. The Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) have approved 19 novel products in 2021. Additionally, last year in 2020, the US FDA has approved …

Insights+: The US FDA New Drug Approvals in March 2021 Read More »

Insights+ Key Biosimilars Events of March 2021

Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency Biosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and the patients During the month of March, Samsung Bioepis Initiated P-I Study of SB17 …

Insights+ Key Biosimilars Events of March 2021 Read More »

The US FDA New Drug Approvals in February 2021

The US FDA has approved 7 NDAs and 1 BLA in Feb 2021, leading to treatments for patients and advances in the health care industry. The Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) have approved 12 novel products in 2021. Additionally, last year in 2020, the US …

The US FDA New Drug Approvals in February 2021 Read More »

The US FDA New Drug Approvals in February 2021

The US FDA has approved 7 NDAs and 1 BLA in Feb 2021, leading to treatments for patients and advances in the health care industry. The Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) have approved 12 novel products in 2021. Additionally, last year in 2020, the US …

The US FDA New Drug Approvals in February 2021 Read More »

Insights+: Breakthrough Therapy Designation by the US FDA in 2020

Breakthrough Therapy (BT) Designation is an expedited review program introduced in Section 902 of the Food and Drug Safety and Innovation Act of 2012 The Breakthrough Designation is granted to the drug candidates as monotherapy or in combination with other drugs intended to treat serious or life-threatening diseases and has shown substantial improvement over available …

Insights+: Breakthrough Therapy Designation by the US FDA in 2020 Read More »

Insights+ Key Biosimilars Events of February 2021

Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency Biosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and the patients During the month of Feb, Biocon collaborated with CHAI to expand access …

Insights+ Key Biosimilars Events of February 2021 Read More »

The US FDA New Drug Approvals in January 2021

The US FDA has approved 4 NDAs in Jan 2021, leading to treatments for patients and advances in the health care industry. The Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) have approved 4 novel products in 2021. Additionally, last year in 2020, the US FDA has approved …

The US FDA New Drug Approvals in January 2021 Read More »

14 major health systems launch data insights company

In an unusual move, 14 major providers — including Trinity Health, CommonSpirit Health and Tenet — have come together to launch a data analytics company. Insights derived from the company’s platform will be available to providers, biopharma companies and scientific researchers working to advance patient care.

Insights+ Key Biosimilars Events of January 2021

Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency Biosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and the patients. Hence, the providers are more likely to adopt biosimilars as a “reference …

Insights+ Key Biosimilars Events of January 2021 Read More »

ViewPoints Interview: Tilak Healthcare’s Edouard Gasser Shares Insights on OdySight

In a recent interview with PharmaShots, Edouard Gasser, CEO of Tilak Healthcare shared his views on OdySight, which is the first medical game to monitor eyesight for patients with chronic eye diseases. Shots: OdySight is a free mobile game and medical-grade application used to remotely monitor patients suffering from chronic maculopathies such as AMD, macular …

ViewPoints Interview: Tilak Healthcare’s Edouard Gasser Shares Insights on OdySight Read More »

Kaiser Permanente joins forces with Accenture, Microsoft to improve cloud capabilities

The California-based healthcare organization will work with Accenture and Microsoft to grow and strengthen its cloud capabilities. The enhancements are expected to help Kaiser provide its care teams with data insights to personalize patient care.

ViewPoints Interview: BMS Foundation’s Patricia Mae Doykos Shares Insights on COVID Advocacy Exchange

In a recent interview with PharmaShots, Patricia Mae Doykos, Lead, Health Equity Initiative, and Director, BMS Foundation at Bristol Myers Squibb shared her views on the promotion of health equity and improvement in health outcomes of populations disproportionately affected by serious diseases and conditions. Shots: CAE is a virtual platform that convenes advocacy groups, patients, …

ViewPoints Interview: BMS Foundation’s Patricia Mae Doykos Shares Insights on COVID Advocacy Exchange Read More »

Insights+ Key Biosimilars Events of December 2020

Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency. Biosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and the patients. Hence, the providers are more likely to adopt biosimilars as a “reference …

Insights+ Key Biosimilars Events of December 2020 Read More »

Insights+: Key Deals of JP Morgan Healthcare Conference 2021

This year J.P. Morgan 39th Annual Healthcare Conference was conducted virtually and we witnessed multiple announcements from numerous Biopharma companies An analysis of events and catalysts that were announced at the conference during these days are included in the report. Most of the deals occurred in the first two days of the conference Our PharmaShots …

Insights+: Key Deals of JP Morgan Healthcare Conference 2021 Read More »

Top 20 Life Sciences Deals of 2020 by Total Deal Value

Life sciences companies are gearing up to enter new markets as they look to secure their positions after a spate of M&A, licensing, and research partnerships in 2020 Artios partnered with Merck with an option to license up to 8 oncology programs proving to be the highest valued deal of 2020 with a total deal …

Top 20 Life Sciences Deals of 2020 by Total Deal Value Read More »

Market access of gene therapies across Europe, USA, and Canada: challenges, trends, and solutions

This article was first published by Elinevan Overbeeke, Sissel Michelsen, Mondher Toumi, Hilde Stevens, Mark Trusheim, Isabelle Huys, and StevenSimoens in Drug Discovery Today under a Creative Commons License. Highlights… The post Market access of gene therapies across Europe, USA, and Canada: challenges, trends, and solutions appeared first on DrugPatentWatch – Make Better Decisions.

Insights+: The US FDA New Drug Approvals in December 2020

The US FDA has approved 7 NDAs and 2 BLA in Nov 2020, leading to treatments for patients and advances in the health care industry.   The Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) have approved 105 novel products so far in 2020, including 9 in Dec 2020.   Additionally, last year in 2019, the US FDA has approved …

Insights+: The US FDA New Drug Approvals in December 2020 Read More »

PharmaShots’ Key Highlights of Fourth Quarter 2020

The fourth quarter of 2020 contains multiple initiations of clinical trials, big approvals, and numerous deals. COVID-19 related news remains at the peak in this quarter Multiple companies received regulatory bodies’ EUA for their vaccines and treatments for COVID-19. Initiating with, Regeneron sought the US FDA’s EUA for REGN-COV2 Ab combination while Health Canada accelerated …

PharmaShots’ Key Highlights of Fourth Quarter 2020 Read More »

ViewPoints Interview: Janssen’s Andrew Greenspan Shares Insights on the Data Presented at ACR2020

In a recent interview with PharmaShots, Andrew Greenspan, MD, VP Medical Affairs of Janssen Immunology shared his views on Janssen’s commitment to advance research in rheumatic disease. Shots: Janssen presented clinical trial results in 35 abstracts featuring findings across PsA, RA, and SLE at ACR Convergence 2020 Virtual Scientific Program Sixteen abstracts focus on Tremfya …

ViewPoints Interview: Janssen’s Andrew Greenspan Shares Insights on the Data Presented at ACR2020 Read More »

ViewPoints Interview: GSK’s Dr. Riju Ray Shares Insights on the Role of Community-Based Pulmonologists in Improving COPD Management Among PCPs

In a recent interview with PharmaShots, Dr. Riju Ray, MD, PhD, Senior Medical Lead at GSK, leading US medical affairs across asthma and COPD shared his views on how community-based pulmonologists are improving COPD management and education among referring PCPs. Shots: Pulmonologists identified 12 strong to moderate predictors of future COPD exacerbations, some of which …

ViewPoints Interview: GSK’s Dr. Riju Ray Shares Insights on the Role of Community-Based Pulmonologists in Improving COPD Management Among PCPs Read More »

Pharmaceutical procurement practice aspects

This article was originally published by Abdrhman Mahmoud Gamil in World Journal of Advanced Research and Reviews, 2020, 08(03), 337–349 under a Creative Commons Attribution Liscense 4.0.  Abstract Procurement is… The post Pharmaceutical procurement practice aspects appeared first on DrugPatentWatch – Make Better Decisions.

Artificial intelligence in drug discovery: what is realistic, what are illusions? Part 1: Ways to make an impact, and why we are not there yet

This article was originally published by Andreas Bender and Isidro Cortes-Ciriano in Drug Discovery Today under a Creative Commons license. Although artificial intelligence (AI) has had a profound impact on… The post Artificial intelligence in drug discovery: what is realistic, what are illusions? Part 1: Ways to make an impact, and why we are not …

Artificial intelligence in drug discovery: what is realistic, what are illusions? Part 1: Ways to make an impact, and why we are not there yet Read More »

Insights+: COVID-19 Healthcare News Monthly Updates – December 2020

Our planet is facing a major pandemic outbreak due to COVID-19 and health agencies are taking every measure to stop it. The COVID-19 virus has been named “SARS-CoV-2” (severe acute respiratory syndrome coronavirus and the disease it causes has been named “Coronavirus Disease 2019” (COVID-19). The outbreak of the respiratory disease was first detected in …

Insights+: COVID-19 Healthcare News Monthly Updates – December 2020 Read More »

PharmaShots’ Most Read News of 2020

“Lockdown’ declared Collins Dictionary word of the year. The year 2020, well known as COVID-19 year has been a busy year for global pharma and biotech companies involved in M&A, option & licensing agreements, and gaining approvals. Our team has compiled a list of 30 most read life sciences news on PharmaShots in 2020. 1. …

PharmaShots’ Most Read News of 2020 Read More »

PharmaShots Wishes you a Merry Christmas and a Happy New Year

Shots: Thank you for your overwhelming affection and support throughout the year. This year we achieved a massive increase in subscribers PharmaShots mobile app is ready and we planned to launch our PharmaShots mobile app in January 2021 May this holiday season fills your life with happiness and wealth. Wish you a Merry Christmas and …

PharmaShots Wishes you a Merry Christmas and a Happy New Year Read More »

Indian Pharma—Some Challenges and Acceptances

This article was originally published by Sajna T. in Management Insight, 16(1):38-40 under a creative commons license. Abstract Business enterprises are an important organ of society. The impact of a… The post Indian Pharma—Some Challenges and Acceptances appeared first on DrugPatentWatch – Make Better Decisions.

Insights+: The US FDA New Drug Approvals in November 2020

The US FDA has approved 5 NDAs and 1 BLA in Nov 2020, leading to treatments for patients and advances in the health care industry. The Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) have approved 96 novel products so far in 2020, including 6 in Nov 2020. …

Insights+: The US FDA New Drug Approvals in November 2020 Read More »

Essential Medicines and Patents

Mark Schultz and Jaci McDole recently used DrugPatentWatch to complete a report on recent trends in the latest editions of the world health organization essential medicines list. Some of their key… The post Essential Medicines and Patents appeared first on DrugPatentWatch – Make Better Decisions.

Insights+ Key Biosimilars Events of November 2020

Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency. Biosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and the patients. Hence, the providers are more likely to adopt biosimilars as a “reference …

Insights+ Key Biosimilars Events of November 2020 Read More »

Insights+: COVID-19 Healthcare News Monthly Updates – November 2020

Our planet is facing a major pandemic outbreak due to COVID-19 and health agencies are taking every measure to stop it. The COVID-19 virus has been named “SARS-CoV-2” (severe acute respiratory syndrome coronavirus 2) and the disease it causes has been named “Coronavirus Disease 2019” (COVID-19). The outbreak of the respiratory disease was first detected …

Insights+: COVID-19 Healthcare News Monthly Updates – November 2020 Read More »

Prescient Announces Recent Appointments to its Senior Team

Prescient hires three new senior members to expand its expertise and keep pace with the company’s growth LONDON, November 3, 2020 – Prescient, a biopharma product and portfolio strategy partner, announces the recent appointment of three new senior members: Gordon Gochenauer, Dr. Priya Kar and Dr. Cameron Mackenzie. They join the existing leadership team, which …

Prescient Announces Recent Appointments to its Senior Team Read More »

Insights+: The US FDA New Drug Approvals in October 2020

The US FDA has approved 4 NDAs and 1 BLA in Oct 2020, leading to treatments for patients and advances in the health care industry. The Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) have approved 90 novel products so far in 2020, including 5 in Oct 2020. …

Insights+: The US FDA New Drug Approvals in October 2020 Read More »

Insights+ Key Biosimilars Events of October 2020

Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency. Biosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and the patients. Hence, the providers are more likely to adopt biosimilars as a “reference …

Insights+ Key Biosimilars Events of October 2020 Read More »

ViewPoints Interview: Eli Lilly’s Dr. Lotus Mallbris Shares Insights on Mirikizumab

In a recent interview with PharmaShots, Dr. Lotus Mallbris, the Vice President of Immunology Development at Eli Lilly shares her insights and highlights on Mirikizumab.  Shots: @52wks. ~60% achieved endoscopic responses (58.5% in IV dosing group and 58.7% in the SC group) while 45% + achieved PRO remission (46.3% in the IV group and 45.6% in the …

ViewPoints Interview: Eli Lilly’s Dr. Lotus Mallbris Shares Insights on Mirikizumab Read More »

Insights+: COVID-19 Healthcare News Monthly Updates – October 2020

Our planet is facing a major pandemic outbreak due to COVID-19 and health agencies are taking every measure to stop it. The COVID-19 virus has been named “SARS-CoV-2” (severe acute respiratory syndrome coronavirus 2) and the disease it causes has been named “Coronavirus Disease 2019” (COVID-19). The outbreak of the respiratory disease was first detected …

Insights+: COVID-19 Healthcare News Monthly Updates – October 2020 Read More »

PharmaShots’ Key Highlights of Third Quarter 2020

The third quarter of 2020 was flooded with major acquisitions in the pharma and biotech industry along with multiple approvals. Starting with the latest acquisitions, Gilead acquired Immunomedics for ~$21B, Illumina acquired GRAIL for ~$8B, J&J acquired Momenta Pharmaceuticals for $6.5B and Nestlé acquired Aimmune Therapeutics for $2.6B, Sanofi acquired Principia Biopharma for ~$3.68B  Apart …

PharmaShots’ Key Highlights of Third Quarter 2020 Read More »

ViewPoints Interview: Takeda’s Andrea Stancati Shares Insights on Entyvio (vedolizumab) SC Formulation

In a recent interview with PharmaShots, Andrea Stancati, Vice President, Head GI Global Medical Franchise shares his insights and highlights of Entyvio (vedolizumab) Shots: The ongoing P-IIIb VISIBLE OLE study involves assessing of Entyvio (SC) in adult patients with UC or CD, following enrolment and participation in the VISIBLE 1 (UC) or VISIBLE 2 (CD) …

ViewPoints Interview: Takeda’s Andrea Stancati Shares Insights on Entyvio (vedolizumab) SC Formulation Read More »

ViewPoints Interview: QIAGEN’s Kai te Kaat Shares Insights on QIAprep&amp Viral RNA UM Kit

In a recent interview with PharmaShots, Kai te Kaat, the Vice President, Head of Franchise Oncology, MDx at QIAGEN shares his insights and highlights on QIAprep&amp Viral RNA UM Kit. Shots: QIAGEN to launch the QIAprep&amp Viral RNA UM Kit, designed to simplify and accelerate PCR swab analysis and remove key testing bottlenecks for Covid-19 and other …

ViewPoints Interview: QIAGEN’s Kai te Kaat Shares Insights on QIAprep&amp Viral RNA UM Kit Read More »

Insights+: The US FDA New Drug Approvals in September 2020

The US FDA has approved 6 NDAs in Sept 2020, leading to treatments for patients and advances in the health care industry. The Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) have approved 85 novel products so far in 2020, including 6 in Sept 2020. Additionally, last year …

Insights+: The US FDA New Drug Approvals in September 2020 Read More »

Freedom of Information Act Access to an Investigational New Drug Application

This article not subject to U.S. Copyright. Published 2019 by the American Chemical Society. Noel T. Southall Abstract We report our experience working with the US Food and Drug Administration… The post Freedom of Information Act Access to an Investigational New Drug Application appeared first on DrugPatentWatch – Make Better Decisions.

Insights+ Key Biosimilars Events of September 2020

Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency. Biosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and the patients. Hence, the providers are more likely to adopt biosimilars as a “reference …

Insights+ Key Biosimilars Events of September 2020 Read More »

Insights+: The US FDA New Drug Approvals in July 2020

The US FDA has approved multiple NDAs and BLAs in July 2020, leading to treatments for patients and advances in the health care industry. The Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) have approved 59 novel products so far in 2020, including 8 in July 2020. Additionally, …

Insights+: The US FDA New Drug Approvals in July 2020 Read More »

Investing in Drug Companies? Here are 6 Vital Non-Patent Factors to Consider

When drug patents expire, billions of dollars in revenues can disappear overnight as competitors enter the market. Accordingly, many investors focus on drug patents when evaluating drug companies. But, there… The post Investing in Drug Companies? Here are 6 Vital Non-Patent Factors to Consider appeared first on DrugPatentWatch – Make Better Decisions.

Generic Drugs Approved but not Launched – How to Tell When Generic Drugs Will hit the Market

Just because a drug has received FDA approval does not mean that it is available in the marketplace. But, why would a company go through all the trouble and expense… The post Generic Drugs Approved but not Launched – How to Tell When Generic Drugs Will hit the Market appeared first on DrugPatentWatch – Make …

Generic Drugs Approved but not Launched – How to Tell When Generic Drugs Will hit the Market Read More »

Insights+ Key Biosimilars Events of July 2020

Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency. Biosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and the patients. Hence, the providers are more likely to adopt biosimilars as a “reference …

Insights+ Key Biosimilars Events of July 2020 Read More »

Insights+ KOL Articles: The New Normal and Covid-19 Vaccine Development

Since the virus outbreak in China, all eyes are on the most awaited Covid-19 vaccine offering a glimmer of hope. Abide by social distancing, wearing a mask, and frequent hand washing – until we have a vaccine. This new mantra amidst all misery has created hope in the hearts of many. We have to accept …

Insights+ KOL Articles: The New Normal and Covid-19 Vaccine Development Read More »

Insights+ Exclusive: COVID-19 Healthcare News Monthly Updates – July 2020

Our planet is facing a major pandemic outbreak due to COVID-19 and health agencies are taking every measure to stop it. The COVID-19 virus has been named “SARS-CoV-2” (severe acute respiratory syndrome coronavirus 2) and the disease it causes has been named “Coronavirus Disease 2019” (COVID-19). The outbreak of the respiratory disease was first detected …

Insights+ Exclusive: COVID-19 Healthcare News Monthly Updates – July 2020 Read More »

Free Patent Litigation Docket Reports Data

The USPTO Office of the Chief Economist has releases a comprehensive set of patent litigation data files for public use. The Patent Litigation Dataset has been updated as of December… The post Free Patent Litigation Docket Reports Data appeared first on DrugPatentWatch – Make Better Decisions.

PharmaShots Celebrates Successful Accomplishment of Two Years

Shots: PharmaShots started its journey in July 2018 as a concise news delivery service and is proud to announce the completion of two years, with many more to come. Till now, PharmaShots has published 3,057 posts delivered to our 3000+ subscribers On the 2nd anniversary, PharmaShots announced “PharmaShots Bespoke” its new tailor-made, and targeted news …

PharmaShots Celebrates Successful Accomplishment of Two Years Read More »

Insights+ Exclusive: The US FDA New Drug Approvals in June 2020

 The US FDA has approved multiple NDAs and BLAs in Jun 2020, leading to treatments for patients and advances in the health care industry. The Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) have approved 51 novel products so far in 2020, including 8 in Jun 2020. Additionally, …

Insights+ Exclusive: The US FDA New Drug Approvals in June 2020 Read More »

Free Orange Book PDF Library from DrugPatentWatch

The FDA Orange Book, or Approved Drug Products with Therapeutic Equivalence Evaluations, is the definitive source to link drugs with the patents that protect them. Over the years we’ve had… The post Free Orange Book PDF Library from DrugPatentWatch appeared first on DrugPatentWatch – Make Better Decisions.

Prescient Announces Recent Appointments to the Senior Advisory Team

Prescient hires two new senior members to support its fast-growing Advisory business LONDON, July 20, 2020—Prescient, a biopharma product and portfolio strategy firm, announces the recent appointment of two new senior members, Peter Donachie and Dr. Haroon Khan, to its Advisory business. They join our specialist team focused on helping clients develop and commercialize assets …

Prescient Announces Recent Appointments to the Senior Advisory Team Read More »

Insights+ Interview: Paige’s CEO, Leo Grady Shares Insights on its Series B Funding and the FDA’s 510(k) Clearance for FullFocus Viewer

Paige is a global digital pathology founded in 2017 by Thomas Fuchs, Dr. Sc., and colleagues from Memorial Sloan Kettering Cancer Center. The company involves computational pathology products that are targeted for patients and their care teams for effective, more informed treatment decisions. Paige has developed a platform to deliver novel technology to pathologists to …

Insights+ Interview: Paige’s CEO, Leo Grady Shares Insights on its Series B Funding and the FDA’s 510(k) Clearance for FullFocus Viewer Read More »

Top 20 Prescription Drugs Based on 2019 Revenue

The average life expectancy span of Human Beings are increased due to better medical facilities and drugs developed by Biopharma companies. Pharmaceutical products or drugs or medicines are being produced for a wide range of medical sectors. It includes the lifesaving drugs or the major therapy area including immunology, cardiology, and neurology but are they …

Top 20 Prescription Drugs Based on 2019 Revenue Read More »

A comprehensive review of database resources in chemistry

This article was originally published by Syed Sauban Ghani in Eclética Química under a Creative Commons license. ABSTRACT As scientific community worldwide is publishing a huge number of research articles… The post A comprehensive review of database resources in chemistry appeared first on DrugPatentWatch – Make Better Decisions.

Common Drugs with Effective Off-Label Uses

This article was originally published by Mohammed M. Alshehri and Mahmoud M. E. Mudawi in the Journal of Pharmaceutical Research International under the terms of the Creative Commons Attribution License.… The post Common Drugs with Effective Off-Label Uses appeared first on DrugPatentWatch – Make Better Decisions.

DrugPatentWatch and Bloomberg: Are there too many generic patent challenges?

Check out this Bloomberg Law article where DrugPatentWatch shows how the number of patent challenges is increasing, while the number of challengers of each patent is also increasing. Why might this… The post DrugPatentWatch and Bloomberg: Are there too many generic patent challenges? appeared first on DrugPatentWatch – Make Better Decisions.

Customer Success: Formulary Management

In response to customer requests, we’ve built some new tools for formulary management. You can preview these tools at: Recent Generic Drug Launches Upcoming 180-Day Patent Challenge Exclusivity Expirations Anticipate… The post Customer Success: Formulary Management appeared first on DrugPatentWatch – Make Better Decisions.

Drug repurposing patent documents vs peer review: patent information comes more than 600 days earlier on average

This article was originally published by Hermann Mucke & Peter Mucke in Future Drug Discovery under a Attribution-NonCommercial-NoDerivatives 4.0 Unported License. https://doi.org/10.4155/fdd-2020-0001. Drug developers require access to scientific information in… The post Drug repurposing patent documents vs peer review: patent information comes more than 600 days earlier on average appeared first on DrugPatentWatch – Make …

Drug repurposing patent documents vs peer review: patent information comes more than 600 days earlier on average Read More »

Customer Success: DrugPatentWatch for Your Library

One of our clients, the Belarus Republican Scientific and Technical Library recently posted an article on how they support innovation. They open with the statement that “The novelty, effectiveness and… The post Customer Success: DrugPatentWatch for Your Library appeared first on DrugPatentWatch – Make Better Decisions.

The effect of patent expiration on sales of branded competitor drugs in a therapeutic class

DrugPatentWatch was used in a recent research study on branded drug sales following generic entry. In this paper, authors Jeffrey Fujimoto, Daniel M Tien, Sophie Snyder, Jeppe A Hertz, and… The post The effect of patent expiration on sales of branded competitor drugs in a therapeutic class appeared first on DrugPatentWatch – Make Better Decisions.

Customer Success: Will a generic version of a drug launch? And when?

DrugPatentWatch serves companies across the drug development-delivery sector. A common request among drug manufacturers, payers, and suppliers alike is anticipation of which branded drugs will face generic competition, and when… The post Customer Success: Will a generic version of a drug launch? And when? appeared first on DrugPatentWatch – Make Better Decisions.

Customer Success: API and CDMO Business Development

Changes in drug markets can create growth opportunities for API manufacturers and CDMOs alike. Whether change comes from generic entry, from new formulations of drugs, or from competition from novel… The post Customer Success: API and CDMO Business Development appeared first on DrugPatentWatch – Make Better Decisions.

Customer Success: Law Firm Business Development

DrugPatentWatch has deep resources to support patent prosecution and patent litigation, but it is also used by law firms for business development. Find weak claims One of the first tweaks… The post Customer Success: Law Firm Business Development appeared first on DrugPatentWatch – Make Better Decisions.

Mistakes to Be Avoided When Preparing a Drug Launch

The launch of a new product can be a daunting task. The main reason this happens is that no matter how many times your company has managed to enter new… The post Mistakes to Be Avoided When Preparing a Drug Launch appeared first on DrugPatentWatch – Make Better Decisions.

Development of the generic drug industry in the US after the Hatch-Waxman Act of 1984

This article was originally published by Garth Boehm, Lixin Yao, Liang Hana, and Qiang Zheng in Acta Pharmaceutica Sinica under a creative commons license. Abstract The key events in the… The post Development of the generic drug industry in the US after the Hatch-Waxman Act of 1984 appeared first on DrugPatentWatch – Make Better Decisions.

Customer Success: How do we identify generic entrants before they get FDA approval?

DrugPatentWatch can help identify generic entrants at the earliest stages Many clients come to DrugPatentWatch seeking to identify generic entrants well before they launch. CDMOs, equipment manufacturers, regulatory consultants, and… The post Customer Success: How do we identify generic entrants before they get FDA approval? appeared first on DrugPatentWatch – Make Better Decisions.

DrugPatentWatch Headlines Swissbiotech Annual Report

The latest Swiss Biotech annual report focuses on the theme of shaping change. Change is a theme DrugPatentWatch is very familiar with — whether it is a matter of tracking… The post DrugPatentWatch Headlines Swissbiotech Annual Report appeared first on DrugPatentWatch – Make Better Decisions.

Why Follow-On Pharmaceutical Innovations Should Be Eligible For Patent Protection

This article was originally published by Christopher M. Holman* in Intellectual Property Watch under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License. Despite the important role of intellectual property rights in… The post Why Follow-On Pharmaceutical Innovations Should Be Eligible For Patent Protection appeared first on DrugPatentWatch – Make Better Decisions.

The Influence of Emerging Markets on the Pharmaceutical Industry

This paper was originally published by  Maya Tannoury and Zouhair Attieh in Current Therapeutic Research under a creative commons license. Abstract Emerging markets represent an exceptional opportunity for the pharmaceutical… The post The Influence of Emerging Markets on the Pharmaceutical Industry appeared first on DrugPatentWatch – Make Better Decisions.