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Articles by Emily Dwyer
Former CFL player from Thorold turns heart attack into mission for change
Dan Giancola, a former Canadian Football League player, isn’t one to shy away from talking about his health-care journey. “I'm an emotional person,” says Giancola. Five years after suffering a heart attack, Giancola has become an advocate for raising awareness about cardiovascular disease and the toll it takes on both physical and mental health.
Queering Climate Action: A Transformative Task
LGBTIQ+ organizations and activists increasingly speak of “queering” systems such as global climate action, , or humanitarian response. Sometimes, this is a rhetorical reboot of existing strategies for increasing inclusion, with ‘queer’ used as a reclaimed shorthand for LGBTIQ+ people. The process of tweaking existing social and economic systems to address climate change and security threats should also certainly ensure the inclusion of LGBTQI+ people.
Designing Dreams
What attracted you to this profession? My love and passion for design. Combining colors, patterns, and personality to create something cohesive. Do you have a favorite design style? Believe it or not, I don’t have a favorite design style. I appreciate and love a well-balanced design. To me, that means a blend of traditional and modern, creating the most interesting and unique aesthetic. From where do you get your design inspiration?
Commonwealth Sanofi damages decision delivered by full court: Sanofi avoids damages payment to the Commonwealth in clopidogrel decision
The Full Federal Court handed down its decision this morning in the longstanding dispute as to whether the Commonwealth can claim under the “undertaking as to damages” a patentee (here Sanofi) is required to give to a generic (here Apotex, and others) as a condition of a preliminary injunction.
I’ll cry about it later - Katy Perry appeals AU trade mark loss
On Thursday, Katy Perry appealed the first instance decision of the Federal Court of Australia which found that her company Kitty Purry Inc infringed the trade mark rights of Australian designer Katie Jane Taylor (born Katie Perry) (Taylor). Taylor is the owner of Australian trade mark 1264761 KATIE PERRY® registered in class 25 for clothes. Taylor has sold clothes under this trade mark in Australia since about 2007.
BioBlast w/e 03 Mar 23:
Significant biosimilar activities this week include: 28 February 2023 | IN | Enzene Biosciences begins supply of Humira® (adalimumab) biosimilar in India Biospectrum India reported that Enzene Biosciences has launched its adalimumab (biosimilar to AbbVie’s Humira®) in India for the treatment of ankylosis spondylitis and rheumatoid arthritis. Enzene believes that this is the first commercial launch using continuous manufacturing technology, which will reduce COGS.
BioBlast w/e 24 Feb 23: Abbvie in hot water over Humira® pricing, Celltrion’s Yuflyma® delays explained, Merck/Moderna mRNA vaccine/ Keytruda treatment, French Court overturns Novartis/Roche €444M cartel fine, Amgen’s Amjevita® savings, Genetech new biolo
Significant biosimilar activities this week include: 22 February 2023 | EU | AbbVie sued by Dutch group over Humira® pricing The Financial Times has reported that the Dutch Pharmaceutical Accountability Foundation (PAF), a public interest group, is suing Abbvie for allegedly overcharging citizens for Humira® (adalimumab) in Holland. PAF is arguing that the pricing of the drug is in breach of human rights. AbbVie has rejected the allegations.
BioBlast w/e 17 Feb 2023: Takeda’s vedolizumab trials, Organon’s financial results, Biora’s PGN-OB1 trials, Fresenius Kabi’s pegfilgrastim, Henlius’ trastuzumab, Coherus/Junshi Biosciences’ toripalimab trials, Similis Bio/Novel 351K biosimilars partnershi
Significant biosimilar activities this week include: 18 Feb 23 | Takeda publishes results of Ph III trials of vedolizumab in preventing intestinal acute graft-versus-host disease Takeda published the results of Ph III trials of vedolizumab in the prevention of intestinal acute graft-versus-host disease (aGvHD) in patients undergoing allogeneic hematopoietic stem cell transplantation (allo-HSCT).
BioBlast f/e 10 Feb 2023: Alvotech’s ustekinumab & omalizumab, new US indication for Eylea®, Sandoz’s US denosumab biosimilar, Amgen US Amjevita® (adalimumab) launch, Sandoz’s citrate-free adalimumab, Celltrion’s Vegzelma™ (bevacizumab), Merck Keytruda® t
Significant biosimilar activities this week include: 09 Feb 23 | EU | EMA accepts MAA for Alvotech’s AVT04 (ustekinumab biosimilar) Alvotech and STADA announced that EMA has accepted the MAA for Alvotech’s AVT04 biosimilar to Janssen’s Stelara™. The companies expect the EMA to recommend AVT04 for approval as early as the second half of 2023. In January 2023, the FDA accepted for review the BLA for AVT04.
BioBlast® w/e 27 Jan 23: Alvotech Simlandi® (biosimilar adalimumab) approval, Alvotech completes private placement round, PTAB institutes Mylan aflibercept challenges, Dr Reddy’s rituximab, BeiGene’s denosumab, MHRA grants Ximluci® (biosimilar ranibizumab
Significant biosimilar activities this week include: 24 Jan 23 | Saudi Food & Drug Authority approves Alvotech’s Simlandi® (biosimilar adalimumab) Alvotech and Bioventure announced that the Saudi Food & Drug Authority has approved the manufacture and distribution of Simladi™ (AVT02, biosimilar adalimumab).
BioBlast® w/e 13 Jan 23: Alvotech’s golimumab, Alvotech and Fuji commercialisation partnership, Dong-A ST’s ustekinumab, Coherus and Klinge’s deal for US aflibercept, Boan Biotech and CP Qingdao denosumab deal, Rani and Celltrion’s oral ustekinumab biosim
Significant biosimilar activities this week include: 16 Jan 23 | Dong-A ST publishes the results of Ph III trials of DMB-3115 (biosimilar ustekinumab) Korea Biomedical Review reported that Dong-A STl has published the results of its global Ph III trials of DMB-3115 (biosimilar ustekinumab). Dong-A ST reported that the study confirmed the therapeutic equivalence and safety of DMB-3115 compared to Janssen’s Stelara®.
BioBlast® w/e 06 January 2023: Biocon insulin, Alvotech ustekinumab, Celltrion Vegzelma™ (bevacizumab), Lannett’s biosimilar insulin products, Alteogen and Celltrion agreement, Samsung Bioepis adalimumab interchangeability, Amgen’s adalimumab, Ontario bio
Significant biosimilar activities this week include: 07 Jan 23 | Biocon receives complete response letter over insulin-r product. Biocon announced that it has received a complete response letter (CRL) from the FDA in relation to its insulin-r product. Biocon reported that the CRL cites additional data required and that it is in the process of addressing the CRL.
BioBlast w/e 16 Dec 22: Doer Biologics and Merck collaboration, expanded Dupixent® indications, Fresenius US citrate-free Idacio® (adalimumab) approval, Merck and Moderna cancer vaccine trial results, Amgen acquires Horizon, Alvotech lists on Nasdaq Icela
Significant biosimilar activities this week include: 15 Dec 22 | Zhejiang Doer Biologics and Merck clinical trials Zhejiang Doer Biologics announced a clinical trial collaboration agreement with Merck to evaluate DR30303 (humanized anti-Claudin18.2 heavy chain antibody Fc fusion protein) in combination with Keytruda® (pembrolizumab).
Misogynoir : pour que les Carla retrouvent leur liberté d’expression • Pivot
Nous devons développer une réponse adaptée aux diverses formes de misogynie, dont la misogynoir, cette haine dirigée spécialement envers les femmes noires pour les faire taire et qui a pour conséquence de défendre le statu quo sexiste et raciste. La semaine dernière, les réalisatrices du documentaire Je vous salue salope se sont présentées à l’Assemblée nationale pour demander des actions contre la misogynie (haine des femmes) en ligne.
Il n’y a pas que le climat sur Terre : enfin, on parle de biodiversité! • Pivot
C’est un évènement historique qui se déroule en ce moment à Montréal. Je parle évidemment de la Conférence de l’ONU sur la biodiversité (COP15) dont l’objectif n’est rien de moins que d’établir un cadre mondial commun pour restaurer et protéger la biodiversité. Si l’effondrement de la biodiversité est un enjeu aussi important que le dérèglement climatique, on en entend beaucoup moins parler.
Du bon usage de l’analogie religieuse dans la dénonciation du wokisme
Les chroniqueur·euses qui s’attaquent au « wokisme » comparent couramment celui-ci à une nouvelle religion. Mais la comparaison religieuse a des limites, sans compter qu’elle perd de sa pertinence à force d’être surutilisée. À moins de vivre caché·e au fond des bois, difficile d’échapper au « wokisme », terme fourre-tout principalement mobilisé sous la plume d’auteur·trices dont les textes prennent la forme de mises en garde et de dénonciations.
Agissons! Manifeste pour la biodiversité, la justice sociale et écologique
Ce manifeste est rédigé par Raphaël Canet et Ronald Cameron, du Réseau international pour l’innovation sociale et écologique, et co-signé par 125 groupes des quatre coins du monde. Il sera transmis aux responsables de la Conférence de l’ONU pour la biodiversité (COP15) et s’adresse aux représentant·es des gouvernements réuni·es à Montréal pour cet événement. Cela fait 50 ans que l’ONU organise des conférences internationales pour débattre des enjeux environnementaux.
BioBlast w/e 09 Dec 22: Roche’s glofitamab, Paras Biopharma’s new biosimilars division, Biogen’s biosimilar tocilizumab, Alvotech/Stada’s EU Hukyndra® roll out, Biocon closes Viatris biosimilar business
Significant biosimilar activities this week include: 11 Dec 22 | New study reports glofitamab is effective in diffuse large B-cell lymphoma A new Roche study published in the New England Journal of Medicine reported that first in class bispecific (anti-CD20/anti-CD3) antibody glofitamab [CD20-TCB, also known as RG6026] is effective in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL).
« NON » à la Loi contre le travail forcé et « OUI » aux droits humains • Pivot
Le Parlement étudie actuellement un projet de loi qui prétend lutter contre l’esclavage moderne. Bien que le Canada reconnaisse depuis longtemps l’existence de l’esclavage moderne et le fait que des entreprises canadiennes en profitent, le projet de loi à l’étude causera, paradoxalement, plus de tort que de bien.
Why MPs should vote ‘no’ to meaningless anti-slavery legislation and ‘yes’ to human rights
Parliament is currently considering legislation that purports to fight modern slavery. While Canada has long recognized that modern slavery exists and that Canadian companies are profiting from it, the anti-slavery legislation — Bill S-211, the Fighting Against Forced Labour and Child Labour in Supply Chains Act — will, paradoxically, do more harm than good.
BioBlast® w/e 21 Oct 22: Spectrum’s eflapegrastim, Eylea® paediatric exclusivity, Saskatchewan biosimilars switching program, AbbVie acquires DJS Antibodies, Lupin FDA observations, Alvotech and JAMP expand partnership, Alvotech/Fuji Pharma, Biocon’s uste
Significant biosimilar activities this week include: 21 Oct 22 | US | Spectrum Pharmaceuticals launched Rolvedon™ Spectrum Pharmaceuticals announced the US launch of Rolvedon™ (eflapegrastim-xnst), a market which is estimated to be valued at over US$2B.
BioBlast® w/e 14 Oct 22: BioFactura’s ustekinumab, Prestige’s trastuzumab, Merck/Moderna personalised cancer vaccine combo, Regeneron’s aflibercept, Jacobio Pharma/Merck’s cetuximab, Janssen’s guselkumab/golimumab, Alvotech’s aflibercept
Significant biosimilar activities this week include: 14 Oct 22 | BioFactura’s biosimilar ustekinumab shows comparable PK to Stelara® in Ph I trial BioFactura has announced successful completion of its Ph I trials relating to biosimilar ustekinumab candidate BFI-751. The trial in Australia and New Zealand involved 226 subjects and demonstrated bioequivalence of BFI-751 to the US and EU versions of Janssen’s Stelara.
BioBlast® w/e 30 Sep 22: Biogen’s tocilizumab, Celltrion’s bevacizumab, Samsung Bioepis’ aflibercept and ranibizumab, Merck’s pembrolizumab, Intas’ ranibizumab, Pfizer/BioNTech/Moderna COVID vaccine patents, biosimilars executive order
Significant biosimilar activities this week include: 30 Sep 22 | EU | EMA accepts Biogen tocilizumab MAA Biogen announced that the EMA has accepted the MAA for BIIB800 (biosimilar tocilizumab). Biogen holds the rights to commercialise Bio-Thera’s product in all countries excluding China under an April 2021 agreement.
BioBlast® w/e 23 Sep 22: Stada/Alvotech’s adalimumab launch, AZ/Merck olaparib PRC approval, AVEO’s ficlatuzumab US fast-tracked, Sandoz’s denosumab, interchangeability in the EU, Coherus’ US ranibizumab launch, Celltrion invalidates Rituxan® patent, Form
Significant biosimilar activities this week include: 22 Sep 22 | CH | STADA launches Alvotech’s Hukyndra® (100mg/mL adalimumab) in Switzerland Alvotech and STADA announced the launch of Hukyndra® (100mg/mL, citrate free biosimilar adalimumab) in Switzerland. Alvotech reached a settlement with AbbVie in April 2022, enabling the launch of adalimumab across Europe, and STADA has since launched Hukyndra in several European countries from June 2022.
BioBlast® w/e 16 Sep 22: Celltrion ustekinumab Ph III trials, Genentech/Samsung Bioepis’ US Avastin® settlement, Biogen natalizumab suit ats Sandoz/Polpharma, Lupin etanercept Rymti® CA approval, Prestige’s bevacizumab withdrawal, Apotex’s tocilizumab IPR
Significant biosimilar activities this week include: 07 Sep 22 | Celltrion’s ustekinumab biosimilar Ph III trials Yonhap News Agency reported that Celltrion’s ustekinumab biosimilar CT-P43 Ph III trials demonstrated comparable efficacy and safety to Janssen’s Stelara®. Data from the global 28-week study in 509 plaque psoriasis patients was presented at the European Academy of Dermatology and Venereology Congress 2022 in Milan, Italy.
Ultimate Guide to Cookware Care: Cleaning Your Pots & Pans
A good piece of cookware is an investment and, if well looked after, it can last a lifetime. The first few times you use it, the feeling is awesome yet terrifying – you want it to stay in perfect condition but the fact is that it’s there to be used. Of course, your pans will face the common effects of time, they may even acquire a few scratches here and there, so how do we restore that youthful glow?
Business and Human Rights Legislation
*On Monday, May 31st, the Canadian Network on Corporate Accountability (CNCA) released draft model legislation to provide lawmakers with a blueprint for a new international corporate accountability law in Canada. Canadian companies and global supply chains are implicated in human rights abuses and environmental damage around the globe. However, Canada has failed to establish rules that require Canadian companies to respect human rights and the environment overseas.
Modern slavery bill misses the mark
For years, the United Nations and communities harmed by corporate abuse abroad have called on Canada to address the serious human rights violations associated with the overseas operations of Canadian multinationals. Unfortunately, the Modern Slavery Act, proposed earlier this month by a Canadian senator and supported by two members of parliament, would do little, if anything, to prevent exploitation and abuses in the global supply chains of Canadian companies.
Dwyer: Canada’s new corporate responsibility post needs real power
The UN building in New York: United Nations' groups have raised many concerns about human rights and the mining industry. Adam Rountree / THE ASSOCIATED PRESS Canada has a clear choice: Be a world leader or a laggard when it comes to human rights and the mining industry. Canadian mining companies operating overseas have been associated with widespread and egregious human rights abuses including murder and rape. The current system relies on voluntary industry initiatives to respect human rights.
Dwyer: Canada’s new corporate responsibility post needs real power
The UN building in New York: United Nations' groups have raised many concerns about human rights and the mining industry. Adam Rountree / THE ASSOCIATED PRESS Canada has a clear choice: Be a world leader or a laggard when it comes to human rights and the mining industry. Canadian mining companies operating overseas have been associated with widespread and egregious human rights abuses including murder and rape. The current system relies on voluntary industry initiatives to respect human rights.
Dwyer: Canada’s new corporate responsibility post needs real power
The UN building in New York: United Nations' groups have raised many concerns about human rights and the mining industry. Adam Rountree / THE ASSOCIATED PRESS Canada has a clear choice: Be a world leader or a laggard when it comes to human rights and the mining industry. Canadian mining companies operating overseas have been associated with widespread and egregious human rights abuses including murder and rape. The current system relies on voluntary industry initiatives to respect human rights.
Take ESG Ratings With A Grain Of Salt
For good investors, a third-party rating system—for example, credit ratings from Moody’s or Fitch, or mutual fund star ratings—is usually just a first step in an investment decision-making process that involves a lot of other research and analysis. Yet when it comes to environmental, social and governance (ESG) research, a growing number of investors are keen to adopt a third-party rating system as the beginning and end of their process. The simplicity of this idea is appealing.
12 Tips To Improve Your Writing
I have always enjoyed writing. I did well on most of my papers in high school, then I continued my writing career into college as a Professional Writing and Communication double-major. At school, I was writing on a daily basis, but now that I'm home for the summer, I have less time to write. I'm either at work, asleep, or hanging out with my friends, but these are only excuses. There is always time to write.
The Ultimate List of Gainesville's Up-And-Coming Restaurants
There is no question that Gainesville has a competitive food scene. For a relatively small town, Gainesville boasts of a diverse selection of restaurants, ranging from beloved hole-in-the-wall pizza joints (literally, here's looking at you Pizza by the Slice) to fare that will take you around the world and back at Civilization. The scene doesn't stop there, so here is a round-up of the most anticipated new restaurants in Gainesville opening this fall.
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