US

SGS Chooses ECCRT to Train its Pharmacy Team

SGS has selected the European Centre for Clinical Research Training (ECCRT) for the provision of good manufacturing practice (GMP) training of its pharmacy team.

Improve Yield and Predict Anomalies in Your Bioreactor

This paper explores the most important data challenges experienced by the rapidly modernizing pharmaceutical industry and proposes a GxP-compliant, ready-made application as a solution designed to increase efficiency in upstream processes, while maintaining data integrity and compliance.

Syntegon AIM 5

The Syntegon AIM 5 utilizes an AI vision system for the inspection of syringe flanges, stoppers, and cylinders.

Customizable CDMO Solutions

Emergent BioSolutions provides end-to-end service for all your drug substance and product development and manufacturing needs.

Sterilization Techniques for Parenteral Packaging

Thursday, September 16, 2021 at 10am EDT| 7am PDT| 3pm BST| 4pm CEST Choosing the right sterilization technique for your drug product and its packaging is not always a simple decision. Join the webcast on September 15th to learn about standard sterilization processes, be introduced to newer techniques, and understand how these techniques have been …

Sterilization Techniques for Parenteral Packaging Read More »

Takeda’s Exkivity (mobocertinib) Receives the US FDA’s Approval as the First Oral Therapy for EGFR Exon20 Insertion+ NSCLC

Shots: The approval is based on the P-I/II trial evaluating Exkivity (160 mg) in 114 patients with EGFR Exon20 insertion+ NSCLC who received prior Pt-based therapy The results demonstrated ORR (28%) as assessed by IRC & 35% as per investigator, m-DoR (17.5mos.), m-OS (24mos.), and m-PFS (7.3mos.) as per IRC Exkivity is a TKI inhibitor …

Takeda’s Exkivity (mobocertinib) Receives the US FDA’s Approval as the First Oral Therapy for EGFR Exon20 Insertion+ NSCLC Read More »

Technology Forum: The Next Steps for Pharma Manufacturing Efficiency and Effectiveness

Wednesday, September 15, 2021 at 10am EDTDrug manufacturing demands and increased regulatory oversight are prompting pharmaceutical manufacturers to consider new processes for oral solid dose and aseptically processed drugs. A cross-section of industry experts will offer insight on emerging trends, technologies, and processes in this Technology Forum.

BeiGene’s Brukinsa (zanubrutinib) Receives the US FDA’s Accelerated Approval for the Treatment of R/R Marginal Zone Lymphoma

Shots: The approval is based on 2 trials i.e., P-II MAGNOLIA & P-I/II BGB-3111-AU-003 trial evaluate Brukinsa (160mg, bid or 320 mg, qd) in 66 & 20 patients with R/R MZL who received at least 1 anti-CD20-based regimen Both trial demonstrated ORR (56% & 80%), CR rate (20% & 20%) based on assessment using CT …

BeiGene’s Brukinsa (zanubrutinib) Receives the US FDA’s Accelerated Approval for the Treatment of R/R Marginal Zone Lymphoma Read More »

Mapping Out Pharma’s Regulatory Future in Europe

There are expectations that changes to pharma regulations in the EU, forming part of the regions broader strategy for the industry, will be positive and should offer flexibility for industry to advance through innovation.

Best Practices in Manufacturing Inhalation Drugs

When designing and manufacturing a pMDI or DPI combination drug-delivery device, the commercial stage should be kept in mind from the beginning of development.

BeiGene and Novartis Report the US FDA’s Acceptance of BLA for Tislelizumab to Treat Esophageal Squamous Cell Carcinoma

Shots: The BLA submission is based on a P-III RATIONALE 302 trial evaluating the efficacy and safety of tislelizumab vs CT in 1972 patients with advanced or metastatic ESCC who had received prior systemic therapy. The anticipated PDUFA date for the therapy is July 12, 2022 The trial met its 1EPs i.e., the therapy showed …

BeiGene and Novartis Report the US FDA’s Acceptance of BLA for Tislelizumab to Treat Esophageal Squamous Cell Carcinoma Read More »

Vector Laboratories Closes $124 Million Buyout

Vector Laboratories has completed a $124 million cash buyout backed by Thompson Street Capital Partners and will begin an acquisition strategy to expand protein detection capabilities.

Boehringer Ingelheim Signs a Research Agreement with Twist to Discover Therapeutic Antibodies Against Multiple Targets

Shots: Twist to receive an up front for each program and $710M in clinical, regulatory, and commercial milestones for the multiple target discovery programs Boehringer Ingelheim obtains global exclusive rights to develop and commercialize any therapeutic Ab discovered under the collaboration The collaboration will utilize Twist’s Ab libraries that derived from human sequences to discover …

Boehringer Ingelheim Signs a Research Agreement with Twist to Discover Therapeutic Antibodies Against Multiple Targets Read More »

Boehringer Ingelheim and Eli Lilly’s Jardiance (empagliflozin) Receive the US FDA’s Breakthrough Therapy Designation for the Treatment of Heart Failure with Preserved Ejection Fraction

Shots: The designation is based on the P-III EMPEROR-Preserved trial evaluates the safety and efficacy of empagliflozin (10mg, qd) vs PBO in 5,988 patients with chronic HFpEF with/out diabetes The results demonstrated a 21% reduction in risk for the composite 1EPs of CV death or hospitalization for adults with HF. The results were presented at …

Boehringer Ingelheim and Eli Lilly’s Jardiance (empagliflozin) Receive the US FDA’s Breakthrough Therapy Designation for the Treatment of Heart Failure with Preserved Ejection Fraction Read More »

Biogen admits slow Aduhelm launch, as scientists question label again

Shares in Biogen have come under pressure after chief executive Michel Vounatsos admitted that the company is facing a much slower than anticipated rollout of its controversial Alzheimer’s disease therapy Aduhelm. Speaking at a Morgan Stanley conference yesterday, Vounatsos said Biogen may have to revisit its sales forecasts for Aduhelm (aducanumab), which were already “very …

Biogen admits slow Aduhelm launch, as scientists question label again Read More »

Five “Must Ask” Questions for CDMOs v2

Ask these five questions to find a smart CDMO partner for your projects. Probe strategically to experience fewer manufacturing issues, faster approval, and higher ROI.

Accelerate Biomedical and Life Sciences Research and Discovery Processes with the Power of Next-Generation Al

Wednesday, September 8, 2021 at 8am EDT| 5am PDT| 1pm BST| 2pm CEST AI has opened up an enormous amount of possibilities for biomedical and life sciences organizations to use growing volumes of data to accelerate and improve upon critical processes that can speed time to value and improve patient outcomes. Learn how next generation …

Accelerate Biomedical and Life Sciences Research and Discovery Processes with the Power of Next-Generation Al Read More »

Effortless Performance: The LCMS-9030 Q-TOF

Shimadzu’s LCMS-9030 is designed to deliver high-resolution, accurate mass detection with incredibly fast data acquisition rates, allowing scientists to identify and quantify more compounds with greater confidence.

Impel NeuroPharma’s Trudhesa (dihydroergotamine mesylate) Nasal Spray Receives the US FDA’s Approval for the Treatment of Migraine

Shots: The approval is based on the P-III STOP 301 trial evaluates Trudhesa (0.725 mg/spray) in 5650+ patients with migraine with or without aura for 24 or 52 wks. The exploratory efficacy results showed that nasal spray provides rapid, sustained, and consistent symptom relief. The therapy is well-tolerated & no serious TEAEs were observed Trudhesa …

Impel NeuroPharma’s Trudhesa (dihydroergotamine mesylate) Nasal Spray Receives the US FDA’s Approval for the Treatment of Migraine Read More »

Janssen’s Invega Hafyera (paliperidone palmitate) Receives the US FDA’s Approval for the Treatment of Schizophrenia

Shots: The approval is based on a P-III study that evaluates Invega hafyera (q6mos., twice-yearly injectable) vs Invega trinza in 702 adults in a ratio (2:1) aged 18-70yrs. with schizophrenia from 20 countries The results showed non-inferiority on 1EPs of time to 1st relapse @12mos. in ITT & per-protocol analysis sets., patients were relapse-free (92.5% …

Janssen’s Invega Hafyera (paliperidone palmitate) Receives the US FDA’s Approval for the Treatment of Schizophrenia Read More »

Pipette Software Update Tool

The Eppendorf Pipette Software Update Tool provides free software updates for electronic pipettes or multi-dispensers.

Double Planetary Mixers

The ROSS Double Planetary Mixer provides high-precision mixing, granulation, and vacuum drying.

Perforated Coating Pan

The TP R Optima features a flexible arm design and individually controlled air exhaust flaps.

BeiGene’s Brukinsa (zanubrutinib) Receives the US FDA’s Approval for the Treatment of Waldenström’s Macroglobulinemia

Shots: The approval is based on P-III ASPEN trial evaluating Brukinsa (160mg, bid, or 320 mg, qd) vs ibrutinib in 201 patients with WM who harbor an MYD88 mutation The 1EPs of the trial was VGPR rate in the overall ITT population as assessed by IRC. VGPR rate (28% vs 19%) based on the modified …

BeiGene’s Brukinsa (zanubrutinib) Receives the US FDA’s Approval for the Treatment of Waldenström’s Macroglobulinemia Read More »

Bio-Thera and Hikma Sign an Exclusive Commercialization and License Agreement for BAT2206 (biosimilar, ustekinumab) in the US

Shots: Bio-Thera to receive $20M up front and $130M as development and commercial milestones and will be responsible for the development, manufacturing, and supply of BAT2206 Hikma get exclusive rights to commercialize the biosimilar in the US and received first-right-to-negotiate to add Europe (excluding CIS countries) BAT2206 is a mAb, that is a proposed biosimilar …

Bio-Thera and Hikma Sign an Exclusive Commercialization and License Agreement for BAT2206 (biosimilar, ustekinumab) in the US Read More »

MicroTransponder Receives the US FDA’s Approval for Vivistim System as the First Vagus Nerve Stimulation Implant for Stroke Rehabilitation

Shots: The approval is based on a study of 108 patients in the US and the UK, that showed patients treated with the Vivistim system had improved mobility than patients in the control group The device used in conjunction with rehabilitation therapy to improve motor function in the hands & arms following ischemic stroke. The …

MicroTransponder Receives the US FDA’s Approval for Vivistim System as the First Vagus Nerve Stimulation Implant for Stroke Rehabilitation Read More »

FSD Pharma to Acquire Lucid Psycheceuticals

FSD Pharma has entered a definitive agreement to acquire all of the issued and outstanding shares of Lucid Psycheceuticals for approximately US$9 million (CAD$11.3 million) in FSD Pharma stock.

Ascendis’ Skytrofa (lonapegsomatropin-tcgd) Receives the US FDA’s Approval for Pediatric Growth Hormone Deficiency

Shots: The approval is based on the P-III heiGHt trial evaluating Skytrofa (qw) vs somatropin in 161 treatment-naïve children ≥aged 1yrs. with GHD who have growth failure due to inadequate secretion of endogenous GH The study met its 1EPs i.e., non-inferiority in AHV & showed a higher AHV @52wks., no serious AEs or discontinuations related …

Ascendis’ Skytrofa (lonapegsomatropin-tcgd) Receives the US FDA’s Approval for Pediatric Growth Hormone Deficiency Read More »

Insilico Biotechnology Joins Inno4vac Project

Insilico Biotechnology has joined the Inno4vac project—an innovative European public-private partnership aimed at accelerating vaccine R&D timelines.

BioAgilytix Acquires Australian-Based CRO 360biolabs

BioAgilytix, a US-based contract research laboratory focused on large-molecule drug development, has agreed to purchase 360biolabs, an Australia-based contract research organization specializing in virology and immunology.

First-in-Human to Commercial: A Microdosing Journey

Thursday, August 26, 2021 at 11am EDT| 8am PDT| 4pm BST| 5pm CEST This webcast will explore the benchmark practices for rapid progression from first-in-human to large-scale commercial manufacture for microdosing API. Micro-dosing at a commercial scale made effortless.

CC Bio Gains Seed Funding Boost from CMS Ventures

CC Bio has raised £890,000 (US $1.2 million) in seed funding from CMS Ventures to accelerate the development of an innovative approach to infection treatment and prevention.

Thermo Fisher’s Oncomine Dx Target Test Receives the US FDA’s Approval as a CDx for the Treatment of IDH1-Mutated Cholangiocarcinoma

Shots: The FDA has approved the Oncomine Dx target test as a CDx to identify patients with IDH1 mutated CCA who may be candidates for Servier’s Tibsovo Oncomine Dx Target Test is NGS based CDx test that provides robust results in the IDH1 gene clinically associated with CCA & is currently approved in 15+ countries, …

Thermo Fisher’s Oncomine Dx Target Test Receives the US FDA’s Approval as a CDx for the Treatment of IDH1-Mutated Cholangiocarcinoma Read More »

Pfizer and BioNTech’s Comirnaty Receive the US FDA’s Approval to Prevent COVID-19 in Individuals Aged 16 Years and Older

Shots: The approval is based on the longer-term follow-up data from the P-III trial that showed high efficacy and favorable safety profile through 6mos. after the second dose The vaccine will now be marketed as Comirnaty and is fully approved for the prevention of COVID-19 in individuals aged ≥16 yrs. The companies also plan to …

Pfizer and BioNTech’s Comirnaty Receive the US FDA’s Approval to Prevent COVID-19 in Individuals Aged 16 Years and Older Read More »

Using Artificial Intelligence in a Digital Twin Strategy

Monday, August 23, 2021 at 2pm EDT | 1pm CDT | 11am PDT What do Plato, Roombas, and digital twins for pharma manufacturing have in common? Learn how digital twins, powered by artificial intellingence, can reproduce conditions happening in physical assets to identify and optimize manufacturing process variables, predict outcomes, and empower to bio/pharma companies …

Using Artificial Intelligence in a Digital Twin Strategy Read More »

Roche’s Ventana MMR RxDx Panel Test Receives the US FDA’s Approval as First CDx to Detect dMMR Solid Tumor

Shots: The FDA has approved the Ventana MMR RxDx Panel test as a CDx to identify patients with dMMR advanced solid tumors, who may be eligible for Jemperli monothx., based on the results of the MMR biomarker test Ventana MMR RxDx Panel provides access to clinicians with fully automated panel of MMR biomarkers tested by …

Roche’s Ventana MMR RxDx Panel Test Receives the US FDA’s Approval as First CDx to Detect dMMR Solid Tumor Read More »

Boehringer Ingelheim and Eli Lilly’s Jardiance (empagliflozin) Receive the US FDA’s Approval for the Treatment of Heart Failure with Reduced Ejection Fraction

Shots: The approval is based on the P-III EMPEROR-Reduced trial evaluating the effect of Jardiance (10 mg, qd) vs PBO in 3730 adults with HFrEF with/out T2D The results demonstrated a 25% reduction in the relative risk of the primary composite EPs of time to CV death or hospitalization for HF. The 2EPs demonstrated 30% …

Boehringer Ingelheim and Eli Lilly’s Jardiance (empagliflozin) Receive the US FDA’s Approval for the Treatment of Heart Failure with Reduced Ejection Fraction Read More »

Agios Reports the US FDA’s Acceptance of NDA and Priority Review for Mitapivat to Treat Pyruvate Kinase Deficiency

Shots: The NDA & MAA submissions are based on ongoing 2 studies i.e., ACTIVATE & ACTIVATE-T evaluates safety, tolerability & efficacy of mitapivat vs PBO in patients with PKD Results: 40% of patients achieved a hemoglobin response, 33% reduction in transfusion burden @ 24wks. fixed dose period & safety profile was consistent with previously reported …

Agios Reports the US FDA’s Acceptance of NDA and Priority Review for Mitapivat to Treat Pyruvate Kinase Deficiency Read More »

Eli Lilly’s Lyumjev (insulin lispro-aabc injection) Receives the US FDA’s Expanded Label Approval for the Treatment of Type 1 and Type 2 Diabetes

Shots: The approval is based on P-III PRONTO-PUMP-2, a treat-to-target study that evaluates the efficacy & safety of Lyumjev (insulin lispro-aabc injection, 100 units/mL) vs Humalog (insulin lispro injection, 100 units/mL) in 432 adults in a ratio (1:1) with T1D for 16wks. The study met its 1EPs i.e., non-inferior A1C reduction from baseline @16wks. Lyumjev …

Eli Lilly’s Lyumjev (insulin lispro-aabc injection) Receives the US FDA’s Expanded Label Approval for the Treatment of Type 1 and Type 2 Diabetes Read More »

2021 PDA/FDA Joint Regulatory Conference – Celebrating 30 Years

The Co-chairs of the 2021 PDA/FDA Joint Regulatory Conference Program Planning Committee share their insights about this important conference, now in its 30th year. They will discuss the importance of hitting this significant milestone, what noted regulatory and industry speakers will be presenting, what’s new this year, what popular sessions are making a return, and …

2021 PDA/FDA Joint Regulatory Conference – Celebrating 30 Years Read More »

The US FDA Rejects Sesen Bio’s Vicineum (oportuzumab monatox-qqrs) for the Treatment of BCG-Unresponsive NMIBC

Shots: The company has received the FDA’s CRL declining the approval of Vicineum’s BLA to treat BCG-unresponsive NMIBC The FDA has provided recommendations to conduct additional clinical/statistical data and analyses of roxadustat in addition to CMC issues related to a recent pre-approval inspection and product quality The company plans to meet with the FDA as …

The US FDA Rejects Sesen Bio’s Vicineum (oportuzumab monatox-qqrs) for the Treatment of BCG-Unresponsive NMIBC Read More »

Junshi and Coherus’s Toripalimab Receive the US FDA’s Breakthrough Therapy Designation as 1L Treatment of Nasopharyngeal Carcinoma

Shots: The designation is based on the P-III JUPITER-02 trial evaluating toripalimab + CT vs CT alone in patients with NPC. The result was presented at ASCO 2021 The results demonstrated an improvement in PFS. The trial also meets 2EPs of PFS assessed by the investigator and ORR as assessed by BIRC including higher DoR; …

Junshi and Coherus’s Toripalimab Receive the US FDA’s Breakthrough Therapy Designation as 1L Treatment of Nasopharyngeal Carcinoma Read More »

Jazz’ Xywav Receives the US FDA’s Approval for the Treatment of Idiopathic Hypersomnia

Shots: The approval is based on the P-III withdrawal study that evaluates the efficacy and safety of Xywav (twice or once-nightly regimen, oral solution) vs PBO in adults with IH. The therapy is expected to be available in late 2021, following REMS implementation The results demonstrated the change in the 1EPs of ESS score & …

Jazz’ Xywav Receives the US FDA’s Approval for the Treatment of Idiopathic Hypersomnia Read More »

Five “Must Ask” Questions for CDMOs

Ask these five questions to find a smart CDMO partner for your projects. Probe strategically to experience fewer manufacturing issues, faster approval, and higher ROI.

C4T’s CFT7455 Receives the US FDA’s Orphan Drug designation for the Treatment of Multiple Myeloma

Shots: The US FDA has granted ODD to CFT7455 for the treatment of MM. The FDA grants ODD to drugs & biologics that are intended for the safe and effective treatment, diagnosis or prevention of rare diseases, or conditions that affect fewer than 200,000 people in the US In Jun’21, the company has initiated a …

C4T’s CFT7455 Receives the US FDA’s Orphan Drug designation for the Treatment of Multiple Myeloma Read More »

Merck’s Keytruda (pembrolizumab) + Lenvima (lenvatinib) Receive the US FDA’s Approval as 1L Treatment of Advanced Renal Cell Carcinoma

Shots: The approval is based on P-III CLEAR /KEYNOTE-581 trial that evaluates Keytruda (200 mg, IV, q3w) + Lenvima (20 mg, PO, qd) or Lenvima (18mg) + everolimus (5mg, PO, qd) vs sunitinib (50 mg, q4w) in a ratio (1:1:1) in 1,069 patients with advanced RCC The results demonstrated an improvement in PFS with a …

Merck’s Keytruda (pembrolizumab) + Lenvima (lenvatinib) Receive the US FDA’s Approval as 1L Treatment of Advanced Renal Cell Carcinoma Read More »

The US FDA’s Rejects FibroGen’s Roxadustat for the Treatment of Anemia Due to CKD

Shots: The company has received an FDA’s CRL declining the approval of roxadustat’s NDA to treat anemia of CKD The FDA has requested to conduct an additional clinical study of roxadustat before resubmission The therapy is approved in China, Japan, Chile, and South Korea for the treatment of anemia of CKD in both NDD and …

The US FDA’s Rejects FibroGen’s Roxadustat for the Treatment of Anemia Due to CKD Read More »

Boston’s EXALT Model B Single-Use Bronchoscope Receives the US FDA’s Clearance for Bronchoscopy Procedures

Shots: The US FDA has granted 510(k) clearance for EXALT Model B single-use Bronchoscope to use in bedside procedures within ICU and OR and will be available in the US in the coming wks. The device is being used for bronchoscopy procedures including secretion management, airway intubation, percutaneous tracheostomy, double-lumen endotracheal tube placement, and biopsies …

Boston’s EXALT Model B Single-Use Bronchoscope Receives the US FDA’s Clearance for Bronchoscopy Procedures Read More »

Merck Reports the US FDA’s Acceptance of Keytruda’s sBLA for Review to Treat MSI-H/dMMR Advanced Endometrial Carcinoma

Shots: The application is based on ORR data from cohorts D & K of KEYNOTE-158 trial evaluating Keytruda as monothx. (200 mg, q3w) in 90 patients with MSI-H/dMMR advanced EC with disease progression following prior systemic therapy in any setting & are not candidates for curative surgery or radiation This indication is approved under accelerated …

Merck Reports the US FDA’s Acceptance of Keytruda’s sBLA for Review to Treat MSI-H/dMMR Advanced Endometrial Carcinoma Read More »

Dermavant Reports the US FDA’s Acceptance of NDA for Tapinarof Cream to Treat Plaque Psoriasis

Shots: The NDA is based on P-III PSOARING 1 & 2 along with interim results from PSOARING 3 OLE study evaluating the safety & efficacy of tapinarof vs vehicle in patients with PsO In PSOARING 1 & 2 results: patients achieved a PGA score of 0 or 1 (35.4% vs 6% & 40.2% vs 6.3%) …

Dermavant Reports the US FDA’s Acceptance of NDA for Tapinarof Cream to Treat Plaque Psoriasis Read More »

EMA Endorses Track-and-Trace Recommendations

The agency is endorsing recommendations for global track-and-trace systems developed by the International Coalition of Medicines Regulatory Authorities.

Key Trends Shaping the Pharma Industry

After a disruptive year in the pharma industry, it’s time to adapt to the next normal. Learn about the four main trends shaping the evolving industry.

Merck Reports the US FDA’s Acceptance of sBLA and Priority Review for Keytruda (pembrolizumab) as an Adjuvant Treatment for RCC

Shots: The sBLA is based on P-III KEYNOTE-564 trial evaluating Keytruda monothx. (200mg, IV on day 1 of each 3wks. cycle for ~17 cycles) vs PBO in 994 patients with RCC, following nephrectomy and resection of metastatic lesions The results demonstrated an improvement in DFS and were presented at ASCO 2021 with an anticipated PDUFA …

Merck Reports the US FDA’s Acceptance of sBLA and Priority Review for Keytruda (pembrolizumab) as an Adjuvant Treatment for RCC Read More »

Atovaquone Oral Suspension Recalled

KVK Tech is voluntarily recalling two lots of Atovaquone Oral Suspension, USP 750 mg/5mL because of customer complaints of unusual grittiness in the product.

FDA Issues NIR Guidance

The guidance aids in the development, validation, and use of near infrared-based analytical procedures.

Calliditas Receives the US FDA’s Fast Track Designation for Setanaxib to Treat Primary Biliary Cholangitis

Shots: The US FDA has granted FTD to selinexor (NOX inhibitor) for the treatment of PBC. Additionally, the therapy has previously received ODD for PBC in the US & EU The P-II clinical trial of the therapy demonstrated anti-fibrotic activity as measured by Fibroscan and showed favorable tolerability profile along with the impact on fatigue …

Calliditas Receives the US FDA’s Fast Track Designation for Setanaxib to Treat Primary Biliary Cholangitis Read More »

Practical Applications of Artificial Intelligence to Gain Insights in Pharma Manufacturing

Artificial Intelligence (AI) is changing how biotech and pharmaceutical companies operate. Increased competition and an enhanced regulatory landscape are forcing drug manufacturers to eliminate waste, create efficiencies and squeeze every last bit of productivity out of existing processes. The benefits can be enormous. A three percent increase in usable yield could increase revenue by millions …

Practical Applications of Artificial Intelligence to Gain Insights in Pharma Manufacturing Read More »

CMA Fines Advanz for Over-Pricing Liothyronine Tablets

CMA fines Advanz and investors for more than £100 million (approximately US$139 million) after the company increased the price of thyroid tablet packs from £20 (US$23.74) in 2009 to £248 (approximately US$295) in 2017.

Packaging for Stability Studies: to Outsource or Not?

Developers might invest in small-scale equipment to produce packaging for stability studies in-house, or they might outsource production. Manufacturers should consider the benefits and risks to both approaches.

PharmaShots Interview: Xencor’s Bassil I. Dahiyat Shares Insight on the US FDA’s Approval of COVID-19 Antibody Treatment Leveraging its Technology

In an interview with PharmaShots, Dr. Bassil I. Dahiyat, President and CEO of Xencor shared his views on the company’s collaborations with BMS and its Xtend XmAb technology. He also shed light on the EUA of Sotrovimab for COVID-19. Shots: The FDA has granted EUA to Vir and GSK’s sotrovimab, which was engineered with Xencor’s …

PharmaShots Interview: Xencor’s Bassil I. Dahiyat Shares Insight on the US FDA’s Approval of COVID-19 Antibody Treatment Leveraging its Technology Read More »

Roche Reports the US FDA’s Acceptance of BLA and Priority Review of Tecentriq (atezolizumab) as an Adjuvant Treatment for NSCLC

Shots: The application is based on the P-III IMpower010 study evaluating the efficacy & safety of Tecentriq vs BSC in 1005 patients in a ratio (1:1) with Stage IB-IIIA NSCLC, following surgical resection and up to 4 cycles of adjuvant cisplatin-based CT The results from an interim analysis showed the reduction in the risk of …

Roche Reports the US FDA’s Acceptance of BLA and Priority Review of Tecentriq (atezolizumab) as an Adjuvant Treatment for NSCLC Read More »

Abbott Launches Jot Dx Insertable Cardiac Monitor to Detect Abnormal Heart Rhythms in US

Shots: Abbott launches its latest Jot Dx ICM with new features to help clinicians for a constant flow of heart rhythm data to treat atrial fibrillation Jot Dx ICM allows 24/7 heart monitoring and connects directly with Abbott’s myMerlin smartphone app. The technology is designed to provide remote detection and improved diagnostic accuracy of cardiac …

Abbott Launches Jot Dx Insertable Cardiac Monitor to Detect Abnormal Heart Rhythms in US Read More »